{
"NDC": [
{
"NDCCode": "70436-059-22",
"PackageDescription": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-22) ",
"NDC11Code": "70436-0059-22",
"ProductNDC": "70436-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211347",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "70436-228-49",
"PackageDescription": "1 BOTTLE in 1 CARTON (70436-228-49) / 22.5 mL in 1 BOTTLE",
"NDC11Code": "70436-0228-49",
"ProductNDC": "70436-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217036",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240607",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].",
"Description": "Azithromycin for Oral Suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70436-059-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-01) ",
"NDC11Code": "70436-0059-01",
"ProductNDC": "70436-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211347",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "70436-059-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-02) ",
"NDC11Code": "70436-0059-02",
"ProductNDC": "70436-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211347",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "70436-059-05",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-05) ",
"NDC11Code": "70436-0059-05",
"ProductNDC": "70436-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211347",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "62331-059-31",
"PackageDescription": "22.5 kg in 1 DRUM (62331-059-31) ",
"NDC11Code": "62331-0059-31",
"ProductNDC": "62331-059",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Atovaquone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20070409",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Divi's Laboratories Limited",
"SubstanceName": "ATOVAQUONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-07-29",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "09-APR-07"
},
{
"NDCCode": "78952-070-22",
"PackageDescription": ".059 L in 1 BOTTLE (78952-070-22) ",
"NDC11Code": "78952-0070-22",
"ProductNDC": "78952-070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cure Well Advanced Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200614",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BluSky Partners LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200614",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "78952-270-22",
"PackageDescription": ".059 L in 1 BOTTLE (78952-270-22) ",
"NDC11Code": "78952-0270-22",
"ProductNDC": "78952-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Well Advanced Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200706",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BluSky Partners LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200706",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "70436-010-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-02) ",
"NDC11Code": "70436-0010-02",
"ProductNDC": "70436-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-010-04",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-04) ",
"NDC11Code": "70436-0010-04",
"ProductNDC": "70436-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-010-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-06) ",
"NDC11Code": "70436-0010-06",
"ProductNDC": "70436-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-011-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02) ",
"NDC11Code": "70436-0011-02",
"ProductNDC": "70436-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-011-04",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04) ",
"NDC11Code": "70436-0011-04",
"ProductNDC": "70436-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-011-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06) ",
"NDC11Code": "70436-0011-06",
"ProductNDC": "70436-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-014-04",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) ",
"NDC11Code": "70436-0014-04",
"ProductNDC": "70436-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-014-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) ",
"NDC11Code": "70436-0014-06",
"ProductNDC": "70436-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-015-04",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-015-04) ",
"NDC11Code": "70436-0015-04",
"ProductNDC": "70436-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-015-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-015-06) ",
"NDC11Code": "70436-0015-06",
"ProductNDC": "70436-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-016-04",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-016-04) ",
"NDC11Code": "70436-0016-04",
"ProductNDC": "70436-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-016-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-016-06) ",
"NDC11Code": "70436-0016-06",
"ProductNDC": "70436-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-017-04",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-017-04) ",
"NDC11Code": "70436-0017-04",
"ProductNDC": "70436-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 10; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-017-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-017-06) ",
"NDC11Code": "70436-0017-06",
"ProductNDC": "70436-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 10; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-018-04",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70436-018-04) ",
"NDC11Code": "70436-0018-04",
"ProductNDC": "70436-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 10; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-018-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-018-06) ",
"NDC11Code": "70436-0018-06",
"ProductNDC": "70436-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 10; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-020-82",
"PackageDescription": "10 VIAL in 1 CARTON (70436-020-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "70436-0020-82",
"ProductNDC": "70436-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212332",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "70436-021-82",
"PackageDescription": "10 VIAL in 1 CARTON (70436-021-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "70436-0021-82",
"ProductNDC": "70436-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212332",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "70436-022-82",
"PackageDescription": "1 VIAL in 1 CARTON (70436-022-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "70436-0022-82",
"ProductNDC": "70436-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215821",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210206",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION."
},
{
"NDCCode": "70436-023-82",
"PackageDescription": "1 VIAL in 1 CARTON (70436-023-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "70436-0023-82",
"ProductNDC": "70436-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215821",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210206",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION."
},
{
"NDCCode": "70436-122-32",
"PackageDescription": "7.5 mL in 1 VIAL, SINGLE-DOSE (70436-122-32) ",
"NDC11Code": "70436-0122-32",
"ProductNDC": "70436-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadobutrol",
"NonProprietaryName": "Gadobutrol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217480",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GADOBUTROL",
"StrengthNumber": "604.72",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N"
},
{
"NDCCode": "70436-122-34",
"PackageDescription": "15 mL in 1 VIAL, SINGLE-DOSE (70436-122-34) ",
"NDC11Code": "70436-0122-34",
"ProductNDC": "70436-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadobutrol",
"NonProprietaryName": "Gadobutrol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217480",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GADOBUTROL",
"StrengthNumber": "604.72",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70436-059-22</NDCCode>
<PackageDescription>250 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-22) </PackageDescription>
<NDC11Code>70436-0059-22</NDC11Code>
<ProductNDC>70436-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211347</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70436-228-49</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70436-228-49) / 22.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70436-0228-49</NDC11Code>
<ProductNDC>70436-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217036</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].</IndicationAndUsage>
<Description>Azithromycin for Oral Suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70436-059-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-01) </PackageDescription>
<NDC11Code>70436-0059-01</NDC11Code>
<ProductNDC>70436-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211347</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70436-059-02</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-02) </PackageDescription>
<NDC11Code>70436-0059-02</NDC11Code>
<ProductNDC>70436-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211347</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70436-059-05</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-05) </PackageDescription>
<NDC11Code>70436-0059-05</NDC11Code>
<ProductNDC>70436-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211347</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of Bupropion Hydrochloride Extended-Release Tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion Hydrochloride Extended-Release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1, 1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are supplied for oral administration as 100-mg (light blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C blue No. 1 aluminum lake and FD&C blue No. 2 aluminum lake; the 150-mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, and the 200-mg tablet contains FD&C red No. 40 aluminum lake. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>62331-059-31</NDCCode>
<PackageDescription>22.5 kg in 1 DRUM (62331-059-31) </PackageDescription>
<NDC11Code>62331-0059-31</NDC11Code>
<ProductNDC>62331-059</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Atovaquone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20070409</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Divi's Laboratories Limited</LabelerName>
<SubstanceName>ATOVAQUONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-29</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-APR-07</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>78952-070-22</NDCCode>
<PackageDescription>.059 L in 1 BOTTLE (78952-070-22) </PackageDescription>
<NDC11Code>78952-0070-22</NDC11Code>
<ProductNDC>78952-070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cure Well Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200614</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BluSky Partners LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200614</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78952-270-22</NDCCode>
<PackageDescription>.059 L in 1 BOTTLE (78952-270-22) </PackageDescription>
<NDC11Code>78952-0270-22</NDC11Code>
<ProductNDC>78952-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Well Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BluSky Partners LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200706</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70436-010-02</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-02) </PackageDescription>
<NDC11Code>70436-0010-02</NDC11Code>
<ProductNDC>70436-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-010-04</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-04) </PackageDescription>
<NDC11Code>70436-0010-04</NDC11Code>
<ProductNDC>70436-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-010-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-06) </PackageDescription>
<NDC11Code>70436-0010-06</NDC11Code>
<ProductNDC>70436-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-011-02</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-02) </PackageDescription>
<NDC11Code>70436-0011-02</NDC11Code>
<ProductNDC>70436-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-011-04</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-04) </PackageDescription>
<NDC11Code>70436-0011-04</NDC11Code>
<ProductNDC>70436-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-011-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06) </PackageDescription>
<NDC11Code>70436-0011-06</NDC11Code>
<ProductNDC>70436-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-014-04</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) </PackageDescription>
<NDC11Code>70436-0014-04</NDC11Code>
<ProductNDC>70436-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-014-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) </PackageDescription>
<NDC11Code>70436-0014-06</NDC11Code>
<ProductNDC>70436-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-015-04</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-015-04) </PackageDescription>
<NDC11Code>70436-0015-04</NDC11Code>
<ProductNDC>70436-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-015-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-015-06) </PackageDescription>
<NDC11Code>70436-0015-06</NDC11Code>
<ProductNDC>70436-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-016-04</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-016-04) </PackageDescription>
<NDC11Code>70436-0016-04</NDC11Code>
<ProductNDC>70436-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-016-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-016-06) </PackageDescription>
<NDC11Code>70436-0016-06</NDC11Code>
<ProductNDC>70436-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-017-04</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-017-04) </PackageDescription>
<NDC11Code>70436-0017-04</NDC11Code>
<ProductNDC>70436-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 10; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-017-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-017-06) </PackageDescription>
<NDC11Code>70436-0017-06</NDC11Code>
<ProductNDC>70436-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 10; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-018-04</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70436-018-04) </PackageDescription>
<NDC11Code>70436-0018-04</NDC11Code>
<ProductNDC>70436-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 10; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-018-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-018-06) </PackageDescription>
<NDC11Code>70436-0018-06</NDC11Code>
<ProductNDC>70436-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 10; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-020-82</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70436-020-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>70436-0020-82</NDC11Code>
<ProductNDC>70436-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212332</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>70436-021-82</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70436-021-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>70436-0021-82</NDC11Code>
<ProductNDC>70436-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212332</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridansor S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis(formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3 R*,6 S*( S*),7 S*,22 S*, 23 R*,26 R*,36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[1,6,9] oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>70436-022-82</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70436-022-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>70436-0022-82</NDC11Code>
<ProductNDC>70436-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215821</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
</NDC>
<NDC>
<NDCCode>70436-023-82</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70436-023-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>70436-0023-82</NDC11Code>
<ProductNDC>70436-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215821</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidisor diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficileand for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is an off-white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, it forms a clear, colorless or light to dark tan solution with the pH of the solution between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3 R*,6 S*( S*),7 S*,22 S*,23 R*,26R*, 36 S*,38a S*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl- a-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadi-azacyclohexadecino[4,5- m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (See DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.</Description>
</NDC>
<NDC>
<NDCCode>70436-122-32</NDCCode>
<PackageDescription>7.5 mL in 1 VIAL, SINGLE-DOSE (70436-122-32) </PackageDescription>
<NDC11Code>70436-0122-32</NDC11Code>
<ProductNDC>70436-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadobutrol</ProprietaryName>
<NonProprietaryName>Gadobutrol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217480</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GADOBUTROL</SubstanceName>
<StrengthNumber>604.72</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70436-122-34</NDCCode>
<PackageDescription>15 mL in 1 VIAL, SINGLE-DOSE (70436-122-34) </PackageDescription>
<NDC11Code>70436-0122-34</NDC11Code>
<ProductNDC>70436-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadobutrol</ProprietaryName>
<NonProprietaryName>Gadobutrol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217480</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GADOBUTROL</SubstanceName>
<StrengthNumber>604.72</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>