{
"NDC": [
{
"NDCCode": "0456-2425-20",
"PackageDescription": "2 CASE in 1 CARTON (0456-2425-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2425-20",
"ProductNDC": "0456-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"EndMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "72162-2425-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (72162-2425-2) ",
"NDC11Code": "72162-2425-02",
"ProductNDC": "72162-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofolxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241112",
"SamplePackage": "N",
"IndicationAndUsage": "Click here to enter Indications.",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "0456-2425-60",
"PackageDescription": "6 CASE in 1 CARTON (0456-2425-60) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK (0456-2425-11)",
"NDC11Code": "00456-2425-60",
"ProductNDC": "0456-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"EndMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "0456-2425-63",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0456-2425-63) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2425-63",
"ProductNDC": "0456-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"EndMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "0113-0456-60",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (0113-0456-60) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00113-0456-60",
"ProductNDC": "0113-0456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076777",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130523",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0363-0456-60",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (0363-0456-60) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00363-0456-60",
"ProductNDC": "0363-0456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20061027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076777",
"LabelerName": "Walgreen Company",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130927",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0456-0095-20",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-0095-20) > 2 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-0095-20",
"ProductNDC": "0456-0095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daliresp",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022522",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-0400-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) ",
"NDC11Code": "00456-0400-10",
"ProductNDC": "0456-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "0456-0600-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) ",
"NDC11Code": "00456-0600-10",
"ProductNDC": "0456-0600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "0456-2405-20",
"PackageDescription": "2 CASE in 1 CARTON (0456-2405-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2405-20",
"ProductNDC": "0456-2405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "0456-2410-20",
"PackageDescription": "2 CASE in 1 CARTON (0456-2410-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2410-20",
"ProductNDC": "0456-2410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "0456-2420-20",
"PackageDescription": "2 CASE in 1 CARTON (0456-2420-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2420-20",
"ProductNDC": "0456-2420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphris",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20130930",
"EndMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022117",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "11344-456-20",
"PackageDescription": "44 mL in 1 BOTTLE, PLASTIC (11344-456-20) ",
"NDC11Code": "11344-0456-20",
"ProductNDC": "11344-456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommended for repeated use."
},
{
"NDCCode": "43744-456-20",
"PackageDescription": "15 g in 1 DRUM (43744-456-20)",
"NDC11Code": "43744-0456-20",
"ProductNDC": "43744-456",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Guanethidine Monosulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "GUANETHIDINE MONOSULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "49035-456-20",
"PackageDescription": "200 BLISTER PACK in 1 CARTON (49035-456-20) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "49035-0456-20",
"ProductNDC": "49035-456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20070509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076777",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250822",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "50066-456-20",
"PackageDescription": "1 TUBE in 1 CARTON (50066-456-20) / 56.7 g in 1 TUBE",
"NDC11Code": "50066-0456-20",
"ProductNDC": "50066-456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xray Pain Relief",
"NonProprietaryName": "Menthol, (plus)-, Camphor, (-)-, And Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Genomma Lab USA",
"SubstanceName": "MENTHOL, (+)-; CAMPHOR, (-)-; METHYL SALICYLATE",
"StrengthNumber": "100; 40; 300",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2023-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231226",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves the minor aches and pains of muscles and joints associated with:sprainssimple backachearthritisstrainsbruises."
},
{
"NDCCode": "51079-456-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-456-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-456-01) ",
"NDC11Code": "51079-0456-20",
"ProductNDC": "51079-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060710",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076052",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060710",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "51811-456-20",
"PackageDescription": "9 mL in 1 BOTTLE, SPRAY (51811-456-20) ",
"NDC11Code": "51811-0456-20",
"ProductNDC": "51811-456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Hanover Pen Corp dba HPC Global",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "5.985",
"StrengthUnit": "mL/9mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200120",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "60760-456-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (60760-456-20) ",
"NDC11Code": "60760-0456-20",
"ProductNDC": "60760-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "65084-456-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (65084-456-20)",
"NDC11Code": "65084-0456-20",
"ProductNDC": "65084-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pacerone",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075135",
"LabelerName": "Mckesson Rxpak Inc",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67046-456-20",
"PackageDescription": "20 CAPSULE in 1 BLISTER PACK (67046-456-20) ",
"NDC11Code": "67046-0456-20",
"ProductNDC": "67046-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072741",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170920",
"SamplePackage": "N",
"IndicationAndUsage": "Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.",
"Description": "Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N, N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide hydrochloride is available in 2 mg capsules. Loperamide hydrochloride capsules, USP contain the following inactive ingredients: black iron oxide, colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, and yellow iron oxide. In addition, the black imprinting ink also contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "70954-456-20",
"PackageDescription": "100 TABLET in 1 BOTTLE (70954-456-20) ",
"NDC11Code": "70954-0456-20",
"ProductNDC": "70954-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215563",
"LabelerName": "Novitium Pharma LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211029",
"SamplePackage": "N",
"IndicationAndUsage": "BISOPROLOL FUMARATE TABLETS, USP are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "BISOPROLOL FUMARATE, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1- Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2 C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. BISOPROLOL FUMARATE TABLETS, USP are available as 5 and 10 mg tablets for oral administration.Inactive ingredients include: microcrystalline cellulose, pregelatinized starch, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, iron oxide red and ferrosoferric oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71335-0456-3",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-3) ",
"NDC11Code": "71335-0456-03",
"ProductNDC": "71335-0456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090824",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, eachtablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose,croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown(Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow)."
},
{
"NDCCode": "76420-456-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (76420-456-20) ",
"NDC11Code": "76420-0456-20",
"ProductNDC": "76420-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake."
},
{
"NDCCode": "0527-2425-32",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-32) ",
"NDC11Code": "00527-2425-32",
"ProductNDC": "0527-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211049",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol. FDA approved dissolution method differs from the USP dissolution method."
},
{
"NDCCode": "0527-2425-46",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-46) ",
"NDC11Code": "00527-2425-46",
"ProductNDC": "0527-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211049",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol. FDA approved dissolution method differs from the USP dissolution method."
},
{
"NDCCode": "70518-2425-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70518-2425-1) ",
"NDC11Code": "70518-2425-01",
"ProductNDC": "70518-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075991",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250826",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R*), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24H 36O 5and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "71335-2425-1",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-2425-1) ",
"NDC11Code": "71335-2425-01",
"ProductNDC": "71335-2425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207804",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. 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 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.",
"Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets."
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"Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets."
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"Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets."
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0456-0600-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) </PackageDescription>
<NDC11Code>00456-0600-10</NDC11Code>
<ProductNDC>0456-0600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0456-2405-20</NDCCode>
<PackageDescription>2 CASE in 1 CARTON (0456-2405-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00456-2405-20</NDC11Code>
<ProductNDC>0456-2405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saphris</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022117</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2410-20</NDCCode>
<PackageDescription>2 CASE in 1 CARTON (0456-2410-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00456-2410-20</NDC11Code>
<ProductNDC>0456-2410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saphris</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022117</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2420-20</NDCCode>
<PackageDescription>2 CASE in 1 CARTON (0456-2420-20) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00456-2420-20</NDC11Code>
<ProductNDC>0456-2420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saphris</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<EndMarketingDate>20150101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022117</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>11344-456-20</NDCCode>
<PackageDescription>44 mL in 1 BOTTLE, PLASTIC (11344-456-20) </PackageDescription>
<NDC11Code>11344-0456-20</NDC11Code>
<ProductNDC>11344-456</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43744-456-20</NDCCode>
<PackageDescription>15 g in 1 DRUM (43744-456-20)</PackageDescription>
<NDC11Code>43744-0456-20</NDC11Code>
<ProductNDC>43744-456</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Guanethidine Monosulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>GUANETHIDINE MONOSULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49035-456-20</NDCCode>
<PackageDescription>200 BLISTER PACK in 1 CARTON (49035-456-20) / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49035-0456-20</NDC11Code>
<ProductNDC>49035-456</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076777</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50066-456-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50066-456-20) / 56.7 g in 1 TUBE</PackageDescription>
<NDC11Code>50066-0456-20</NDC11Code>
<ProductNDC>50066-456</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xray Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol, (plus)-, Camphor, (-)-, And Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Genomma Lab USA</LabelerName>
<SubstanceName>MENTHOL, (+)-; CAMPHOR, (-)-; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>100; 40; 300</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves the minor aches and pains of muscles and joints associated with:sprainssimple backachearthritisstrainsbruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51079-456-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-456-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-456-01) </PackageDescription>
<NDC11Code>51079-0456-20</NDC11Code>
<ProductNDC>51079-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060710</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076052</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060710</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51811-456-20</NDCCode>
<PackageDescription>9 mL in 1 BOTTLE, SPRAY (51811-456-20) </PackageDescription>
<NDC11Code>51811-0456-20</NDC11Code>
<ProductNDC>51811-456</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antimicrobial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Hanover Pen Corp dba HPC Global</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>5.985</StrengthNumber>
<StrengthUnit>mL/9mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-456-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (60760-456-20) </PackageDescription>
<NDC11Code>60760-0456-20</NDC11Code>
<ProductNDC>60760-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>65084-456-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (65084-456-20)</PackageDescription>
<NDC11Code>65084-0456-20</NDC11Code>
<ProductNDC>65084-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pacerone</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075135</ApplicationNumber>
<LabelerName>Mckesson Rxpak Inc</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67046-456-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BLISTER PACK (67046-456-20) </PackageDescription>
<NDC11Code>67046-0456-20</NDC11Code>
<ProductNDC>67046-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072741</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.</IndicationAndUsage>
<Description>Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N, N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide hydrochloride is available in 2 mg capsules. Loperamide hydrochloride capsules, USP contain the following inactive ingredients: black iron oxide, colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, and yellow iron oxide. In addition, the black imprinting ink also contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>70954-456-20</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70954-456-20) </PackageDescription>
<NDC11Code>70954-0456-20</NDC11Code>
<ProductNDC>70954-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215563</ApplicationNumber>
<LabelerName>Novitium Pharma LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BISOPROLOL FUMARATE TABLETS, USP are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>BISOPROLOL FUMARATE, USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1- Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2 C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.96. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. BISOPROLOL FUMARATE TABLETS, USP are available as 5 and 10 mg tablets for oral administration.Inactive ingredients include: microcrystalline cellulose, pregelatinized starch, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, iron oxide red and ferrosoferric oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71335-0456-3</NDCCode>
<PackageDescription>20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-3) </PackageDescription>
<NDC11Code>71335-0456-03</NDC11Code>
<ProductNDC>71335-0456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, eachtablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose,croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown(Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow).</Description>
</NDC>
<NDC>
<NDCCode>76420-456-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (76420-456-20) </PackageDescription>
<NDC11Code>76420-0456-20</NDC11Code>
<ProductNDC>76420-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-2425-32</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-32) </PackageDescription>
<NDC11Code>00527-2425-32</NDC11Code>
<ProductNDC>0527-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211049</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol. FDA approved dissolution method differs from the USP dissolution method.</Description>
</NDC>
<NDC>
<NDCCode>0527-2425-46</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-2425-46) </PackageDescription>
<NDC11Code>00527-2425-46</NDC11Code>
<ProductNDC>0527-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211049</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol. FDA approved dissolution method differs from the USP dissolution method.</Description>
</NDC>
<NDC>
<NDCCode>70518-2425-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-2425-1) </PackageDescription>
<NDC11Code>70518-2425-01</NDC11Code>
<ProductNDC>70518-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075991</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R*), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24H 36O 5and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>71335-2425-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-2425-1) </PackageDescription>
<NDC11Code>71335-2425-01</NDC11Code>
<ProductNDC>71335-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207804</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. 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 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.</IndicationAndUsage>
<Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>71335-2425-2</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-2425-2) </PackageDescription>
<NDC11Code>71335-2425-02</NDC11Code>
<ProductNDC>71335-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207804</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. 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 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.</IndicationAndUsage>
<Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets.</Description>
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<ProductNDC>71335-2425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207804</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. 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 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.</IndicationAndUsage>
<Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets.</Description>
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