{
"NDC": [
{
"NDCCode": "70436-196-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-06) ",
"NDC11Code": "70436-0196-06",
"ProductNDC": "70436-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216439",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Tablets are a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1) , 2 improving exercise tolerance in patients with chronic stable angina. ( 1.2) .",
"Description": "Diltiazem Hydrochloride Extended-Release Tablets are a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)-one,3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis-. The structural formula is:. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.99. Diltiazem Hydrochloride Extended-Release Tablets are formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: colloidal silicon dioxide, ethyl acrylate and methyl methacrylate copolymer, ethylcellulose, glyceryl mono and dicaprylocaprate, hypromellose, magnesium stearate, microcrystalline cellulose, nonoxynol 100, polyethylene glycol polyvinyl alcohol graft copolymer, polyethylene oxide, polyvinyl alcohol, povidone, sugar spheres, talc and titanium dioxide."
},
{
"NDCCode": "70436-196-04",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-04) ",
"NDC11Code": "70436-0196-04",
"ProductNDC": "70436-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216439",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Tablets are a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1) , 2 improving exercise tolerance in patients with chronic stable angina. ( 1.2) .",
"Description": "Diltiazem Hydrochloride Extended-Release Tablets are a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)-one,3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis-. The structural formula is:. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.99. Diltiazem Hydrochloride Extended-Release Tablets are formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: colloidal silicon dioxide, ethyl acrylate and methyl methacrylate copolymer, ethylcellulose, glyceryl mono and dicaprylocaprate, hypromellose, magnesium stearate, microcrystalline cellulose, nonoxynol 100, polyethylene glycol polyvinyl alcohol graft copolymer, polyethylene oxide, polyvinyl alcohol, povidone, sugar spheres, talc and titanium dioxide."
},
{
"NDCCode": "10451-003-06",
"PackageDescription": "196 L in 1 CYLINDER (10451-003-06) ",
"NDC11Code": "10451-0003-06",
"ProductNDC": "10451-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19600101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205891",
"LabelerName": "General Distributing Company",
"SubstanceName": "NITROGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19600101",
"SamplePackage": "N"
},
{
"NDCCode": "13537-196-06",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-196-06) > 6 g in 1 BOTTLE (13537-196-05)",
"NDC11Code": "13537-0196-06",
"ProductNDC": "13537-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika 3-in-1 Pro Make Up Foundation Spf 20 Base De Maquillaje Para Rostro 3-en-1 Pro Fps 20",
"ProprietaryNameSuffix": "(rose 3) - Rose",
"NonProprietaryName": "Octinoxate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140306",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .02; .02",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "21130-196-06",
"PackageDescription": "177 mL in 1 BOTTLE, SPRAY (21130-196-06) ",
"NDC11Code": "21130-0196-06",
"ProductNDC": "21130-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care",
"ProprietaryNameSuffix": "Sore Throat Cherry Flavor",
"NonProprietaryName": "Phenol",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "SAFEWAY",
"SubstanceName": "PHENOL",
"StrengthNumber": "1.4",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporarily relief of occasional minor irritation, pain, sore mouth, and sore throat."
},
{
"NDCCode": "54340-196-06",
"PackageDescription": "8 BOTTLE, PUMP in 1 CARTON (54340-196-06) / 221 mL in 1 BOTTLE, PUMP (54340-196-05) ",
"NDC11Code": "54340-0196-06",
"ProductNDC": "54340-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Professional Complete Antibacterial Foaming Hand Wash Original Scent",
"NonProprietaryName": "Dial Professional Complete Antibacterial Foaming Hand Wash Original Scent",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "61152-196-06",
"PackageDescription": "4.5 mL in 1 BOTTLE, SPRAY (61152-196-06) ",
"NDC11Code": "61152-0196-06",
"ProductNDC": "61152-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Snore Stop Extinguisher Throat",
"NonProprietaryName": "Atropa Belladonna, Ephedra Distachya Flowering Twig, Histamine Dihydrochloride, Goldenseal, Potassium Dichromate, Strychnos Nux-vomica Seed, Teucrium Marum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Green Pharmaceuticals",
"SubstanceName": "ATROPA BELLADONNA; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM",
"StrengthNumber": "6; 6; 6; 12; 6; 6; 6",
"StrengthUnit": "[hp_X]/4.5mL; [hp_X]/4.5mL; [hp_X]/4.5mL; [hp_X]/4.5mL; [hp_X]/4.5mL; [hp_X]/4.5mL; [hp_X]/4.5mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Shake before each use. Remove cap. Rotate yellow arm to a right angle. Press down on sprayer until a fine mist apprears. When in bed, spray once under the tongue and once in the back of the throat. For Maximum Results, use minimum 3 nights. ."
},
{
"NDCCode": "63323-196-06",
"PackageDescription": "1 VIAL in 1 BOX (63323-196-06) > 2 mL in 1 VIAL",
"NDC11Code": "63323-0196-06",
"ProductNDC": "63323-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludarabine",
"NonProprietaryName": "Fludarabine Phosphate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078544",
"LabelerName": "APP Pharmaceuticals, LLC",
"SubstanceName": "FLUDARABINE PHOSPHATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66267-196-06",
"PackageDescription": "6 TABLET in 1 BOTTLE (66267-196-06) ",
"NDC11Code": "66267-0196-06",
"ProductNDC": "66267-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161014",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "68180-196-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-196-06) ",
"NDC11Code": "68180-0196-06",
"ProductNDC": "68180-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Amlodipine",
"NonProprietaryName": "Telmisartan And Amlodipine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201586",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; TELMISARTAN",
"StrengthNumber": "5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140108",
"SamplePackage": "N"
},
{
"NDCCode": "68428-196-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-196-06) ",
"NDC11Code": "68428-0196-06",
"ProductNDC": "68428-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ambrosia Artemisiaefolia",
"NonProprietaryName": "Ambrosia Artemisiifolia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100429",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "AMBROSIA ARTEMISIIFOLIA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100429",
"SamplePackage": "N"
},
{
"NDCCode": "70436-004-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70436-004-06) ",
"NDC11Code": "70436-0004-06",
"ProductNDC": "70436-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077604",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170802",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.",
"Description": "Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate."
},
{
"NDCCode": "70436-005-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70436-005-06) ",
"NDC11Code": "70436-0005-06",
"ProductNDC": "70436-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077604",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170802",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.",
"Description": "Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate."
},
{
"NDCCode": "70436-006-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70436-006-06) ",
"NDC11Code": "70436-0006-06",
"ProductNDC": "70436-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine",
"NonProprietaryName": "Galantamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077604",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170802",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.",
"Description": "Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate."
},
{
"NDCCode": "70436-010-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-06) ",
"NDC11Code": "70436-0010-06",
"ProductNDC": "70436-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-011-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06) ",
"NDC11Code": "70436-0011-06",
"ProductNDC": "70436-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "70436-012-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-012-06) ",
"NDC11Code": "70436-0012-06",
"ProductNDC": "70436-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210014",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .",
"Description": "Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "70436-013-06",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-013-06) ",
"NDC11Code": "70436-0013-06",
"ProductNDC": "70436-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210014",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .",
"Description": "Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "70436-014-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) ",
"NDC11Code": "70436-0014-06",
"ProductNDC": "70436-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-015-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-015-06) ",
"NDC11Code": "70436-0015-06",
"ProductNDC": "70436-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-016-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-016-06) ",
"NDC11Code": "70436-0016-06",
"ProductNDC": "70436-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
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"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
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"LabelerName": "Slate Run Pharmaceuticals, LLC",
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"StrengthNumber": "40; 10; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
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"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-018-06",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70436-018-06) ",
"NDC11Code": "70436-0018-06",
"ProductNDC": "70436-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide",
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"ApplicationNumber": "ANDA210718",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 10; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
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"IndicationAndUsage": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "70436-050-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (70436-050-06) ",
"NDC11Code": "70436-0050-06",
"ProductNDC": "70436-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cilostazol",
"NonProprietaryName": "Cilostazol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077208",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "CILOSTAZOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "70436-051-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (70436-051-06) ",
"NDC11Code": "70436-0051-06",
"ProductNDC": "70436-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cilostazol",
"NonProprietaryName": "Cilostazol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077208",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "CILOSTAZOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Deprecated",
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"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
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},
{
"NDCCode": "70436-055-06",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-055-06) ",
"NDC11Code": "70436-0055-06",
"ProductNDC": "70436-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211100",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
},
{
"NDCCode": "70436-057-06",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-06) ",
"NDC11Code": "70436-0057-06",
"ProductNDC": "70436-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211100",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg)."
},
{
"NDCCode": "70436-090-06",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (70436-090-06) ",
"NDC11Code": "70436-0090-06",
"ProductNDC": "70436-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205695",
"LabelerName": "Slate Run Pharmaceuticals, LLC.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180313",
"SamplePackage": "N",
"IndicationAndUsage": "Montelukast sodium chewable tablets are leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 to 14 years of age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of age. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). .",
"Description": "Montelukast Sodium, the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast Sodium is a hygroscopic, optically active, white to off-white powder. Montelukast Sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide red, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulphate."
},
{
"NDCCode": "70436-091-06",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (70436-091-06) ",
"NDC11Code": "70436-0091-06",
"ProductNDC": "70436-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205695",
"LabelerName": "Slate Run Pharmaceuticals, LLC.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180313",
"SamplePackage": "N",
"IndicationAndUsage": "Montelukast sodium chewable tablets are leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 to 14 years of age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of age. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). .",
"Description": "Montelukast Sodium, the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast Sodium is a hygroscopic, optically active, white to off-white powder. Montelukast Sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide red, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulphate."
},
{
"NDCCode": "70436-098-06",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eplerenone",
"NonProprietaryName": "Eplerenone",
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"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "EPLERENONE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
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"IndicationAndUsage": "Eplerenone tablets is an aldosterone antagonist indicated for: 1 Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1), 2 The treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).",
"Description": "Eplerenone tablets contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3‑oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24 H30 O6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below. Eplerenone is white or almost white powder. It is freely soluble in dichloromethane, very slightly soluble in water. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate, titanium dioxide, polyethylene glycol 400, polysorbate 80. In addition, the 50 mg tablets contain iron oxide yellow and iron oxide red."
}
]
}
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<Description>Diltiazem Hydrochloride Extended-Release Tablets are a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)-one,3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis-. The structural formula is:. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.99. Diltiazem Hydrochloride Extended-Release Tablets are formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: colloidal silicon dioxide, ethyl acrylate and methyl methacrylate copolymer, ethylcellulose, glyceryl mono and dicaprylocaprate, hypromellose, magnesium stearate, microcrystalline cellulose, nonoxynol 100, polyethylene glycol polyvinyl alcohol graft copolymer, polyethylene oxide, polyvinyl alcohol, povidone, sugar spheres, talc and titanium dioxide.</Description>
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<ProprietaryName>Esika 3-in-1 Pro Make Up Foundation Spf 20 Base De Maquillaje Para Rostro 3-en-1 Pro Fps 20</ProprietaryName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<NDC>
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<IndicationAndUsage>for the temporarily relief of occasional minor irritation, pain, sore mouth, and sore throat.</IndicationAndUsage>
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<NDC>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Shake before each use. Remove cap. Rotate yellow arm to a right angle. Press down on sprayer until a fine mist apprears. When in bed, spray once under the tongue and once in the back of the throat. For Maximum Results, use minimum 3 nights. .</IndicationAndUsage>
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<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludarabine</ProprietaryName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20100216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68180-196-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-196-06) </PackageDescription>
<NDC11Code>68180-0196-06</NDC11Code>
<ProductNDC>68180-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; TELMISARTAN</SubstanceName>
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<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ambrosia Artemisiaefolia</ProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA</SubstanceName>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70436-004-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-004-06) </PackageDescription>
<NDC11Code>70436-0004-06</NDC11Code>
<ProductNDC>70436-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>70436-005-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-005-06) </PackageDescription>
<NDC11Code>70436-0005-06</NDC11Code>
<ProductNDC>70436-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077604</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>70436-006-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70436-006-06) </PackageDescription>
<NDC11Code>70436-0006-06</NDC11Code>
<ProductNDC>70436-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine</ProprietaryName>
<NonProprietaryName>Galantamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077604</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Galantamine Tablets USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has an empirical formula of C 17H 21NO 3 HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:. Galantamine Tablets USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. The 4 mg tablets contain polyethylene glycol and polysorbate 80. The 8 mg tablets contain D&C red #27, FD&C blue #1, and triacetin. The 12 mg tablets contain FD&C yellow # 6, iron oxide yellow, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>70436-010-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-06) </PackageDescription>
<NDC11Code>70436-0010-06</NDC11Code>
<ProductNDC>70436-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-011-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-011-06) </PackageDescription>
<NDC11Code>70436-0011-06</NDC11Code>
<ProductNDC>70436-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major de pressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients:. cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>70436-012-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-012-06) </PackageDescription>
<NDC11Code>70436-0012-06</NDC11Code>
<ProductNDC>70436-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210014</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-013-06</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-013-06) </PackageDescription>
<NDC11Code>70436-0013-06</NDC11Code>
<ProductNDC>70436-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210014</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Desvenlafaxine Extended-Release Tablets are an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2 (free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine Extended-Release Tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of ferrosoferric oxide, iron oxide red, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, talc and film coating, which consists of D&C red #27, FD&C blue #2, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-014-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06) </PackageDescription>
<NDC11Code>70436-0014-06</NDC11Code>
<ProductNDC>70436-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210718</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-015-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-015-06) </PackageDescription>
<NDC11Code>70436-0015-06</NDC11Code>
<ProductNDC>70436-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
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<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
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<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
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<IndicationAndUsage>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. Amlodipine besylate, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. Hydrochlorothiazide, a component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets contains olmesartan medoxomil, a white to off-white crystalline powder, amlodipine besylate, a white or almost white powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The color coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, the 20 mg/5 mg/12.5 mg tablets contains black iron oxide, red iron oxide and yellow iron oxide; the 40 mg/10 mg/25 mg tablets and 40 mg/10 mg/12.5 mg tablets contains red iron oxide and yellow iron oxide; the 40 mg/5 mg/12.5 mg tablets and 40 mg/5 mg/25 mg tablets contain yellow iron oxide.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70436-055-06</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-055-06) </PackageDescription>
<NDC11Code>70436-0055-06</NDC11Code>
<ProductNDC>70436-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211100</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg).</Description>
</NDC>
<NDC>
<NDCCode>70436-057-06</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-057-06) </PackageDescription>
<NDC11Code>70436-0057-06</NDC11Code>
<ProductNDC>70436-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211100</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Extended-Release Capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended release beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: ammonium hydroxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc. The capsule shell contains FD&C blue 1 (14 mg, 21 mg, 28 mg), FD&C yellow 6 (14 mg, 21 mg, 28 mg), gelatin, titanium dioxide and yellow iron oxide (7 mg, 14 mg). The imprinting ink contains black iron oxide (7 mg, 14 mg, 21 mg), potassium hydroxide (7 mg, 14 mg, 21 mg), shellac and titanium dioxide (28 mg).</Description>
</NDC>
<NDC>
<NDCCode>70436-090-06</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (70436-090-06) </PackageDescription>
<NDC11Code>70436-0090-06</NDC11Code>
<ProductNDC>70436-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205695</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Montelukast sodium chewable tablets are leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 to 14 years of age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of age. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). .</IndicationAndUsage>
<Description>Montelukast Sodium, the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast Sodium is a hygroscopic, optically active, white to off-white powder. Montelukast Sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide red, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulphate.</Description>
</NDC>
<NDC>
<NDCCode>70436-091-06</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (70436-091-06) </PackageDescription>
<NDC11Code>70436-0091-06</NDC11Code>
<ProductNDC>70436-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205695</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Montelukast sodium chewable tablets are leukotriene receptor antagonist indicated for: 1 Prophylaxis and chronic treatment of asthma in patients 2 to 14 years of age( 1.1). , 2 Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 to 14 years of age( 1.2). , 3 Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 to 14 years of age, and perennial allergic rhinitis (PAR) in patients2 to 14 years of age. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3). .</IndicationAndUsage>
<Description>Montelukast Sodium, the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35ClNNaO 3S, and its molecular weight is 608.18. The structural formula is:. Montelukast Sodium is a hygroscopic, optically active, white to off-white powder. Montelukast Sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg chewable montelukast sodium tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide red, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulphate.</Description>
</NDC>
<NDC>
<NDCCode>70436-098-06</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70436-098-06) </PackageDescription>
<NDC11Code>70436-0098-06</NDC11Code>
<ProductNDC>70436-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eplerenone</ProprietaryName>
<NonProprietaryName>Eplerenone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212765</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EPLERENONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eplerenone tablets is an aldosterone antagonist indicated for: 1 Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1), 2 The treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).</IndicationAndUsage>
<Description>Eplerenone tablets contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3‑oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24 H30 O6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below. Eplerenone is white or almost white powder. It is freely soluble in dichloromethane, very slightly soluble in water. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate, titanium dioxide, polyethylene glycol 400, polysorbate 80. In addition, the 50 mg tablets contain iron oxide yellow and iron oxide red.</Description>
</NDC>
</NDCList>