RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>70377-113-11</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (70377-113-11) </PackageDescription>
    <NDC11Code>70377-0113-11</NDC11Code>
    <ProductNDC>70377-113</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217137</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
    <Description>The active ingredient in famotidine for oral suspension USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each 5 mL of famotidine for oral suspension USP when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: anhydrous citric acid, powdered cellulose, sucrose, xanthan gum and banana, cherry and mint flavor. Added as preservatives are methylparaben sodium, propylparaben sodium and sodium benzoate. Famotidine is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and glacial acetic acid; slightly soluble in methanol; very slightly soluble in water; and practically insoluble in chloroform, ether and ethyl acetate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-006-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-11) </PackageDescription>
    <NDC11Code>70377-0006-11</NDC11Code>
    <ProductNDC>70377-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207752</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to:.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2­[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol. Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-007-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-007-11) </PackageDescription>
    <NDC11Code>70377-0007-11</NDC11Code>
    <ProductNDC>70377-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207752</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</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>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to:.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2­[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol. Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-008-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-008-11) </PackageDescription>
    <NDC11Code>70377-0008-11</NDC11Code>
    <ProductNDC>70377-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207752</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</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>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to:.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2­[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol. Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-009-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-009-11) </PackageDescription>
    <NDC11Code>70377-0009-11</NDC11Code>
    <ProductNDC>70377-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207752</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</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>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to:.</IndicationAndUsage>
    <Description>Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2­[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium USP is (C22H27FN3O6S)2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol. Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-010-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-010-11) </PackageDescription>
    <NDC11Code>70377-0010-11</NDC11Code>
    <ProductNDC>70377-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214182</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
    <Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-011-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-011-11) </PackageDescription>
    <NDC11Code>70377-0011-11</NDC11Code>
    <ProductNDC>70377-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214182</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
    <Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-012-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-012-11) </PackageDescription>
    <NDC11Code>70377-0012-11</NDC11Code>
    <ProductNDC>70377-012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214182</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
    <Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-013-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-013-11) </PackageDescription>
    <NDC11Code>70377-0013-11</NDC11Code>
    <ProductNDC>70377-013</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214182</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5).</IndicationAndUsage>
    <Description>Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-014-11</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70377-014-11) </PackageDescription>
    <NDC11Code>70377-0014-11</NDC11Code>
    <ProductNDC>70377-014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212297</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
    <Description>Tacrolimus USP, previously known as FK506, is the active ingredient in Tacrolimus capsules, USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hy-droxy-3-methoxy cyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8- (2-propenyl)-, mono-hydrate, [3S [3R*,E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,-14R*,15S*,16R*,18S*,19S*,26aR*]]-; (-)- (3S,4R,5S,8R, 9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24, 25,26,26ahexadecahydro- 5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4- hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16- dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3Hpyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)- te-trone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off-white powder. It is soluble in methanol, ethanol, acetone, ethyl acetate and chloroform. Insoluble in water. Tacrolimus USP is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose anhydrous NF, croscarmellose sodium NF, hypromellose USP, magnesium stearate NF. The 0.5 mg capsule shell contains ferric oxide yellow, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains ferric oxide red, gelatin NF, and titanium dioxide USP. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The components of red ink used in Tacrolimus capsules USP, 0.5 mg and 1 mg are Shellac, Propylene glycol, Sodium hydroxide, Titanium dioxide, Povidone and FD&amp;C Red Aluminium Lake. The components of white ink used in Tacrolimus capsules USP, 5 mg are Shellac, Propylene glycol, Ammonia solution, Titanium dioxide and Potassium Hydroxide. Tacrolimus capsules meet USP Organic Impurities, Procedure 2. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-015-11</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70377-015-11) </PackageDescription>
    <NDC11Code>70377-0015-11</NDC11Code>
    <ProductNDC>70377-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212297</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
    <Description>Tacrolimus USP, previously known as FK506, is the active ingredient in Tacrolimus capsules, USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hy-droxy-3-methoxy cyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8- (2-propenyl)-, mono-hydrate, [3S [3R*,E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,-14R*,15S*,16R*,18S*,19S*,26aR*]]-; (-)- (3S,4R,5S,8R, 9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24, 25,26,26ahexadecahydro- 5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4- hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16- dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3Hpyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)- te-trone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off-white powder. It is soluble in methanol, ethanol, acetone, ethyl acetate and chloroform. Insoluble in water. Tacrolimus USP is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose anhydrous NF, croscarmellose sodium NF, hypromellose USP, magnesium stearate NF. The 0.5 mg capsule shell contains ferric oxide yellow, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains ferric oxide red, gelatin NF, and titanium dioxide USP. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The components of red ink used in Tacrolimus capsules USP, 0.5 mg and 1 mg are Shellac, Propylene glycol, Sodium hydroxide, Titanium dioxide, Povidone and FD&amp;C Red Aluminium Lake. The components of white ink used in Tacrolimus capsules USP, 5 mg are Shellac, Propylene glycol, Ammonia solution, Titanium dioxide and Potassium Hydroxide. Tacrolimus capsules meet USP Organic Impurities, Procedure 2. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-016-11</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70377-016-11) </PackageDescription>
    <NDC11Code>70377-0016-11</NDC11Code>
    <ProductNDC>70377-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212297</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
    <Description>Tacrolimus USP, previously known as FK506, is the active ingredient in Tacrolimus capsules, USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hy-droxy-3-methoxy cyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8- (2-propenyl)-, mono-hydrate, [3S [3R*,E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,-14R*,15S*,16R*,18S*,19S*,26aR*]]-; (-)- (3S,4R,5S,8R, 9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24, 25,26,26ahexadecahydro- 5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4- hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16- dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3Hpyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)- te-trone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off-white powder. It is soluble in methanol, ethanol, acetone, ethyl acetate and chloroform. Insoluble in water. Tacrolimus USP is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose anhydrous NF, croscarmellose sodium NF, hypromellose USP, magnesium stearate NF. The 0.5 mg capsule shell contains ferric oxide yellow, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains ferric oxide red, gelatin NF, and titanium dioxide USP. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The components of red ink used in Tacrolimus capsules USP, 0.5 mg and 1 mg are Shellac, Propylene glycol, Sodium hydroxide, Titanium dioxide, Povidone and FD&amp;C Red Aluminium Lake. The components of white ink used in Tacrolimus capsules USP, 5 mg are Shellac, Propylene glycol, Ammonia solution, Titanium dioxide and Potassium Hydroxide. Tacrolimus capsules meet USP Organic Impurities, Procedure 2. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-017-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-017-11) </PackageDescription>
    <NDC11Code>70377-0017-11</NDC11Code>
    <ProductNDC>70377-017</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>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>70377-018-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-018-11) </PackageDescription>
    <NDC11Code>70377-0018-11</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>70377-019-11</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (70377-019-11) </PackageDescription>
    <NDC11Code>70377-0019-11</NDC11Code>
    <ProductNDC>70377-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fingolimod</ProprietaryName>
    <NonProprietaryName>Fingolimod</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207979</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fingolimod capsules are 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 patients 10 years of age and older.</IndicationAndUsage>
    <Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride is a white to off white powder that is freely soluble in ethanol, soluble in water and practically insoluble in n-Hexane. It has a molecular weight of 343.93 g/mol. Fingolimod capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each fingolimod capsule 0.5 mg contains the following inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide yellow, magnesium stearate, microcrystalline cellulose, titanium dioxide. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The components of black ink used in fingolimod capsules, 0.5 mg are Shellac, Black iron oxide and Potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-023-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-11) </PackageDescription>
    <NDC11Code>70377-0023-11</NDC11Code>
    <ProductNDC>70377-023</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211470</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablets are indicated: 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S, 3R, 4R, 5S, 6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl) tetrahydro-2H-pyran-3,4,5-triol compound with meso-butane 2,3-diol (1:1) hydrate. The empirical formula is C25H37ClO9 and the molecular weight is 517.01. The structural formula is. Dapagliflozin is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate or the equivalent of 10 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate, and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Contains no ingredient made from a gluten containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-024-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-024-11) </PackageDescription>
    <NDC11Code>70377-0024-11</NDC11Code>
    <ProductNDC>70377-024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin</ProprietaryName>
    <NonProprietaryName>Dapagliflozin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211470</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin tablets are indicated: 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S, 3R, 4R, 5S, 6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl) tetrahydro-2H-pyran-3,4,5-triol compound with meso-butane 2,3-diol (1:1) hydrate. The empirical formula is C25H37ClO9 and the molecular weight is 517.01. The structural formula is. Dapagliflozin is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate or the equivalent of 10 mg dapagliflozin as dapagliflozin butane-2,3-diol monohydrate, and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Contains no ingredient made from a gluten containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-027-11</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (70377-027-11) </PackageDescription>
    <NDC11Code>70377-0027-11</NDC11Code>
    <ProductNDC>70377-027</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>10</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>70377-028-11</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (70377-028-11) </PackageDescription>
    <NDC11Code>70377-0028-11</NDC11Code>
    <ProductNDC>70377-028</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>20</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>70377-029-11</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (70377-029-11) </PackageDescription>
    <NDC11Code>70377-0029-11</NDC11Code>
    <ProductNDC>70377-029</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>40</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>70377-030-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-030-11) </PackageDescription>
    <NDC11Code>70377-0030-11</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>70377-031-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-031-11) </PackageDescription>
    <NDC11Code>70377-0031-11</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>70377-032-11</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>
    <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>70377-033-11</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70377-033-11) </PackageDescription>
    <NDC11Code>70377-0033-11</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>70377-034-11</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-034-11) </PackageDescription>
    <NDC11Code>70377-0034-11</NDC11Code>
    <ProductNDC>70377-034</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211020</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.,</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1   treatment of major depressive disorder (MDD) (1.1), 2   prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
    <Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-035-11</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-11) </PackageDescription>
    <NDC11Code>70377-0035-11</NDC11Code>
    <ProductNDC>70377-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211020</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.,</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1   treatment of major depressive disorder (MDD) (1.1), 2   prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
    <Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-038-11</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11) </PackageDescription>
    <NDC11Code>70377-0038-11</NDC11Code>
    <ProductNDC>70377-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Posaconazole</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220308</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214476</ApplicationNumber>
    <LabelerName>Biocon Phama Inc.</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220308</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows:.  Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows (1.2). ° Posaconazole delayed-release tablets: Adults and pediatric patients 13 years of age and older.</IndicationAndUsage>
    <Description>Posaconazole is an azole antifungal agent. Posaconazole is available as a delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is:. Posaconazole is a white to off white powder with a low aqueous solubility. Posaconazole delayed-release tablet is pale yellow to yellow, oval, biconvex, film coated tablets debossed with ‘B100’ on one side and plain on the other side. Each delayed-release tablet contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and Opadry® II yellow (consists of following ingredients: ferrosoferric oxide, iron Oxide yellow, macrogol/PEG 3350, polyvinyl alcohol partially hydrolyzed, talc and titanium Dioxide).</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-039-11</NDCCode>
    <PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-039-11) </PackageDescription>
    <NDC11Code>70377-0039-11</NDC11Code>
    <ProductNDC>70377-039</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolic Acid</ProprietaryName>
    <NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214630</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>MYCOPHENOLATE SODIUM</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolic acid delayed-release tablets are antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).</IndicationAndUsage>
    <Description>Mycophenolic acid delayed-release tablets, USP are enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is:. Mycophenolic acid, as the sodium salt (mycophenolate sodium, USP), is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, maize starch and povidone (K-30). The enteric coating of the tablet consists of FD &amp; C Blue No. 2 Aluminum Lake (180 mg), ferric oxide red (360 mg), ferric oxide yellow, hypromellose phthalate and titanium dioxide. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-040-11</NDCCode>
    <PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-040-11) </PackageDescription>
    <NDC11Code>70377-0040-11</NDC11Code>
    <ProductNDC>70377-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolic Acid</ProprietaryName>
    <NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214630</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.</LabelerName>
    <SubstanceName>MYCOPHENOLATE SODIUM</SubstanceName>
    <StrengthNumber>360</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolic acid delayed-release tablets are antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).</IndicationAndUsage>
    <Description>Mycophenolic acid delayed-release tablets, USP are enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is:. Mycophenolic acid, as the sodium salt (mycophenolate sodium, USP), is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, maize starch and povidone (K-30). The enteric coating of the tablet consists of FD &amp; C Blue No. 2 Aluminum Lake (180 mg), ferric oxide red (360 mg), ferric oxide yellow, hypromellose phthalate and titanium dioxide. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>70377-045-11</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (70377-045-11) </PackageDescription>
    <NDC11Code>70377-0045-11</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>
</NDCList>