{
"NDC": [
{
"NDCCode": "70377-032-14",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14) ",
"NDC11Code": "70377-0032-14",
"ProductNDC": "70377-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-032-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70377-032-11) ",
"NDC11Code": "70377-0032-11",
"ProductNDC": "70377-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-032-12",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70377-032-12) ",
"NDC11Code": "70377-0032-12",
"ProductNDC": "70377-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-032-13",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (70377-032-13) ",
"NDC11Code": "70377-0032-13",
"ProductNDC": "70377-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-001-14",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70377-001-14) ",
"NDC11Code": "70377-0001-14",
"ProductNDC": "70377-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Biocon Pharma Inc,",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "70377-002-14",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70377-002-14) ",
"NDC11Code": "70377-0002-14",
"ProductNDC": "70377-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Biocon Pharma Inc,",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "70377-003-14",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70377-003-14) ",
"NDC11Code": "70377-0003-14",
"ProductNDC": "70377-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Biocon Pharma Inc,",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "70377-004-14",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70377-004-14) ",
"NDC11Code": "70377-0004-14",
"ProductNDC": "70377-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Biocon Pharma Inc,",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "70377-005-14",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70377-005-14) ",
"NDC11Code": "70377-0005-14",
"ProductNDC": "70377-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "Biocon Pharma Inc,",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "70377-017-91",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (70377-017-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70377-0017-91",
"ProductNDC": "70377-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209639",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230313",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is practically insoluble in acetone, slightly soluble in ethanol, very slightly soluble in polyethylene glycol and isopropanol, and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablet contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, maize starch B, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "70377-018-91",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (70377-018-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70377-0018-91",
"ProductNDC": "70377-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209639",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230313",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is practically insoluble in acetone, slightly soluble in ethanol, very slightly soluble in polyethylene glycol and isopropanol, and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablet contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, maize starch B, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "70377-030-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70377-030-14) ",
"NDC11Code": "70377-0030-14",
"ProductNDC": "70377-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Biocon Pharma Inc.,",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium, USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33 H34FN2O5)2 Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "70377-031-14",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70377-031-14) ",
"NDC11Code": "70377-0031-14",
"ProductNDC": "70377-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-033-14",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70377-033-14) ",
"NDC11Code": "70377-0033-14",
"ProductNDC": "70377-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213680",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red."
},
{
"NDCCode": "70377-045-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70377-045-14) ",
"NDC11Code": "70377-0045-14",
"ProductNDC": "70377-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209869",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "70377-046-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70377-046-14) ",
"NDC11Code": "70377-0046-14",
"ProductNDC": "70377-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209869",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "70377-047-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70377-047-14) ",
"NDC11Code": "70377-0047-14",
"ProductNDC": "70377-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209869",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "70377-048-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70377-048-14) ",
"NDC11Code": "70377-0048-14",
"ProductNDC": "70377-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209869",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N"
},
{
"NDCCode": "70377-185-11",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (70377-185-11) ",
"NDC11Code": "70377-0185-11",
"ProductNDC": "70377-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eltrombopag",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220660",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260909",
"SamplePackage": "N",
"IndicationAndUsage": "Eltrombopag tablets are thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for Eltrombopag olamine is 3'-{(2Z)-2- [1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for Eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of Eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: Hypromellose, titanium dioxide, polyethylene glycol 400, polysorbate 80 (12.5-mg tablet and 25-mg tablet), Iron Oxide yellow (50-mg tablet), Iron oxide Red (50-mg tablet and 75-mg tablet), Iron oxide Black (75-mg tablet)."
},
{
"NDCCode": "11673-032-14",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (11673-032-14) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "11673-0032-14",
"ProductNDC": "11673-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hcl And Pseudoephedrine Hci",
"NonProprietaryName": "Fexofenadine Hcl And Pseudoephedrine Hci",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076667",
"LabelerName": "Target Brands Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "60; 120",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "24338-032-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (24338-032-14) ",
"NDC11Code": "24338-0032-14",
"ProductNDC": "24338-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adthyza",
"ProprietaryNameSuffix": "Thyroid",
"NonProprietaryName": "Levothyroxine And Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "19; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230220",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "ADTHYZA (thyroid tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.",
"Description": "ADTHYZA (thyroid tablets, USP) ADTHYZA (thyroid tablets, USP) has not been approved by FDA as a new drug.for oral use is a natural preparation derived from porcine thyroid glands and may have a characteristic odor. ADTHYZA (thyroid tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 65 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, dextrose, mannitol, microcrystalline cellulose, and sodium starch glycolate. The structural formulas are below."
},
{
"NDCCode": "24909-032-14",
"PackageDescription": "14 g in 1 TUBE (24909-032-14) ",
"NDC11Code": "24909-0032-14",
"ProductNDC": "24909-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Skin Repair",
"NonProprietaryName": "Allantoin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor cuts, scrapes, and burns. Helps prevent, temporarily protect, and relieve chapped or cracked skin."
},
{
"NDCCode": "36800-032-14",
"PackageDescription": "14 POUCH in 1 CARTON (36800-032-14) / 1 h in 1 POUCH",
"NDC11Code": "36800-0032-14",
"ProductNDC": "36800-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Transdermal System",
"NonProprietaryName": "Nicotine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20240625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074612",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "7",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240625",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "42361-032-01",
"PackageDescription": "2 CASE in 1 BOX (42361-032-01) > 14 g in 1 CASE",
"NDC11Code": "42361-0032-01",
"ProductNDC": "42361-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Impact Fix Prism Two Way Cake",
"ProprietaryNameSuffix": "Spf 24, No. 23",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide, Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Dong Sung Pharm. Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
"StrengthNumber": ".9604; .5488; .196",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "45802-032-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-032-01) > 14 g in 1 TUBE",
"NDC11Code": "45802-0032-01",
"ProductNDC": "45802-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolnaftate",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110802",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "61919-032-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (61919-032-14) ",
"NDC11Code": "61919-0032-14",
"ProductNDC": "61919-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203458",
"LabelerName": "DIRECT RX",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170214",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. [Molecular Structure]. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
},
{
"NDCCode": "69097-032-91",
"PackageDescription": "4 CARTON in 1 CARTON (69097-032-91) / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76) ",
"NDC11Code": "69097-0032-91",
"ProductNDC": "69097-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nilotinib",
"NonProprietaryName": "Nilotinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250618",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218922",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "NILOTINIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250618",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "Nilotinib Capsules is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2).",
"Description": "Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C32H28F3N7O7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pKa1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate. Its structure is shown below:. Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "69539-032-41",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (69539-032-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "69539-0032-41",
"ProductNDC": "69539-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209623",
"LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoro methyl phenyl)-amide. Its molecular weight is 270.21, and the structural formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is soluble in N, N-Dimethyl formamide, sparingly soluble in acetone and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet is made of hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "69804-032-14",
"PackageDescription": "28500 mg in 1 BOTTLE, DISPENSING (69804-032-14)",
"NDC11Code": "69804-0032-14",
"ProductNDC": "69804-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Naturally Hl Hand Care",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170125",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Ridge Properties",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71220-032-01",
"PackageDescription": "1 CONTAINER in 1 CARTON (71220-032-01) > 14 g in 1 CONTAINER",
"NDC11Code": "71220-0032-01",
"ProductNDC": "71220-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aqua Fit Cushion N23",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Innisfree Corporation",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "7; 1.66; 1.96",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70377-032-14</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70377-032-14) </PackageDescription>
<NDC11Code>70377-0032-14</NDC11Code>
<ProductNDC>70377-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213680</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>70377-032-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-032-11) </PackageDescription>
<NDC11Code>70377-0032-11</NDC11Code>
<ProductNDC>70377-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213680</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<LastUpdate>2025-07-19</LastUpdate>
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<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
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<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
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<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
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<ProprietaryName>Simvastatin</ProprietaryName>
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<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<Status>Active</Status>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: alcohol, anhydrous citric acid, ascorbic acid, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), purified water, talc, titanium dioxide, triethyl citrate, and butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contains red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209639</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
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<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is practically insoluble in acetone, slightly soluble in ethanol, very slightly soluble in polyethylene glycol and isopropanol, and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablet contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, maize starch B, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>70377-018-91</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (70377-018-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70377-0018-91</NDC11Code>
<ProductNDC>70377-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209639</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to off-white solid that is practically insoluble in acetone, slightly soluble in ethanol, very slightly soluble in polyethylene glycol and isopropanol, and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablet contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, maize starch B, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>70377-030-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70377-030-14) </PackageDescription>
<NDC11Code>70377-0030-14</NDC11Code>
<ProductNDC>70377-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.,</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium, USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33 H34FN2O5)2 Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>70377-031-14</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70377-031-14) </PackageDescription>
<NDC11Code>70377-0031-14</NDC11Code>
<ProductNDC>70377-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213680</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>70377-033-14</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70377-033-14) </PackageDescription>
<NDC11Code>70377-0033-14</NDC11Code>
<ProductNDC>70377-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213680</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain sacubitril sodium and valsartan disodium in the molar ratio of 1:1 respectively. Sacubitril sodium is chemically described as Sodium 4-(((2S, 4R)-1- ([1,1ʹ-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl) amino)-4-oxo butanoate. Valsartan disodium is chemically described as (S)-3-methyl-2-(N-{[2'-(2H-1,2,3,4-tetrazol-5-yl)biphenyl- 4-yl]methyl}pentanamido)disodium butanoate. Empirical formula of sacubitril sodium and valsartan disodium are C24H28NO5Na and C24H27N5Na2O3 respectively. Molecular mass of Sacubitril sodium and Valsartan disodium are 433.48 and 479.49 g/mol respectively. Molecular structure of both drug substances are as below. Sacubitril sodium. Valsartan disodium. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are gmcc (glyceryl monocaprylocaprate) type 1 / glycerol esters of fatty acids, polyvinyl alcohol-part. hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black and iron oxide red. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>70377-045-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70377-045-14) </PackageDescription>
<NDC11Code>70377-0045-14</NDC11Code>
<ProductNDC>70377-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209869</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>70377-046-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70377-046-14) </PackageDescription>
<NDC11Code>70377-0046-14</NDC11Code>
<ProductNDC>70377-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209869</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>70377-047-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70377-047-14) </PackageDescription>
<NDC11Code>70377-0047-14</NDC11Code>
<ProductNDC>70377-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209869</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemia.o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-β,δ,6-trihydroxy-,monosodium salt, [1S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to off-white powder. It is a relatively polar hydrophilic compound with a partition coefficient (n-octanol/water) of 0.59. It is soluble in water (676 mg/mL). Pravastatin sodium, USP is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Croscarmellose sodium, lactose Monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>70377-048-14</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70377-048-14) </PackageDescription>
<NDC11Code>70377-0048-14</NDC11Code>
<ProductNDC>70377-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209869</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70377-185-11</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (70377-185-11) </PackageDescription>
<NDC11Code>70377-0185-11</NDC11Code>
<ProductNDC>70377-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eltrombopag</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220660</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eltrombopag tablets are thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for Eltrombopag olamine is 3'-{(2Z)-2- [1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for Eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of Eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: Hypromellose, titanium dioxide, polyethylene glycol 400, polysorbate 80 (12.5-mg tablet and 25-mg tablet), Iron Oxide yellow (50-mg tablet), Iron oxide Red (50-mg tablet and 75-mg tablet), Iron oxide Black (75-mg tablet).</Description>
</NDC>
<NDC>
<NDCCode>11673-032-14</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (11673-032-14) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0032-14</NDC11Code>
<ProductNDC>11673-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hcl And Pseudoephedrine Hci</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl And Pseudoephedrine Hci</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076667</ApplicationNumber>
<LabelerName>Target Brands Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24338-032-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (24338-032-14) </PackageDescription>
<NDC11Code>24338-0032-14</NDC11Code>
<ProductNDC>24338-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adthyza</ProprietaryName>
<ProprietaryNameSuffix>Thyroid</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>19; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADTHYZA (thyroid tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>ADTHYZA (thyroid tablets, USP) ADTHYZA (thyroid tablets, USP) has not been approved by FDA as a new drug.for oral use is a natural preparation derived from porcine thyroid glands and may have a characteristic odor. ADTHYZA (thyroid tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 65 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, dextrose, mannitol, microcrystalline cellulose, and sodium starch glycolate. The structural formulas are below.</Description>
</NDC>
<NDC>
<NDCCode>24909-032-14</NDCCode>
<PackageDescription>14 g in 1 TUBE (24909-032-14) </PackageDescription>
<NDC11Code>24909-0032-14</NDC11Code>
<ProductNDC>24909-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Skin Repair</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor cuts, scrapes, and burns. Helps prevent, temporarily protect, and relieve chapped or cracked skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-032-14</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (36800-032-14) / 1 h in 1 POUCH</PackageDescription>
<NDC11Code>36800-0032-14</NDC11Code>
<ProductNDC>36800-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Transdermal System</ProprietaryName>
<NonProprietaryName>Nicotine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074612</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42361-032-01</NDCCode>
<PackageDescription>2 CASE in 1 BOX (42361-032-01) > 14 g in 1 CASE</PackageDescription>
<NDC11Code>42361-0032-01</NDC11Code>
<ProductNDC>42361-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Impact Fix Prism Two Way Cake</ProprietaryName>
<ProprietaryNameSuffix>Spf 24, No. 23</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide, Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Dong Sung Pharm. Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.9604; .5488; .196</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-032-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-032-01) > 14 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0032-01</NDC11Code>
<ProductNDC>45802-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolnaftate</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>61919-032-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (61919-032-14) </PackageDescription>
<NDC11Code>61919-0032-14</NDC11Code>
<ProductNDC>61919-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203458</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. [Molecular Structure]. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69097-032-91</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (69097-032-91) / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76) </PackageDescription>
<NDC11Code>69097-0032-91</NDC11Code>
<ProductNDC>69097-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nilotinib</ProprietaryName>
<NonProprietaryName>Nilotinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250618</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218922</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>NILOTINIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250618</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nilotinib Capsules is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2).</IndicationAndUsage>
<Description>Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C32H28F3N7O7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pKa1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate. Its structure is shown below:. Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69539-032-41</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (69539-032-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69539-0032-41</NDC11Code>
<ProductNDC>69539-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209623</ApplicationNumber>
<LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoro methyl phenyl)-amide. Its molecular weight is 270.21, and the structural formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is soluble in N, N-Dimethyl formamide, sparingly soluble in acetone and insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The film coating for the 7 mg and 14 mg tablet is made of hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>69804-032-14</NDCCode>
<PackageDescription>28500 mg in 1 BOTTLE, DISPENSING (69804-032-14)</PackageDescription>
<NDC11Code>69804-0032-14</NDC11Code>
<ProductNDC>69804-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Naturally Hl Hand Care</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Ridge Properties</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71220-032-01</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (71220-032-01) > 14 g in 1 CONTAINER</PackageDescription>
<NDC11Code>71220-0032-01</NDC11Code>
<ProductNDC>71220-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aqua Fit Cushion N23</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Innisfree Corporation</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7; 1.66; 1.96</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>