RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>60219-1420-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1420-9) </PackageDescription>
    <NDC11Code>60219-1420-09</NDC11Code>
    <ProductNDC>60219-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1420-3</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (60219-1420-3) </PackageDescription>
    <NDC11Code>60219-1420-03</NDC11Code>
    <ProductNDC>60219-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-1420-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (69238-1420-9) </PackageDescription>
    <NDC11Code>69238-1420-09</NDC11Code>
    <ProductNDC>69238-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-1420-9</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (71335-1420-9) </PackageDescription>
    <NDC11Code>71335-1420-09</NDC11Code>
    <ProductNDC>71335-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140828</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201278</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1155-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1155-9) </PackageDescription>
    <NDC11Code>60219-1155-09</NDC11Code>
    <ProductNDC>60219-1155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1156-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1156-9) </PackageDescription>
    <NDC11Code>60219-1156-09</NDC11Code>
    <ProductNDC>60219-1156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1157-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1157-9) </PackageDescription>
    <NDC11Code>60219-1157-09</NDC11Code>
    <ProductNDC>60219-1157</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1158-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1158-9) </PackageDescription>
    <NDC11Code>60219-1158-09</NDC11Code>
    <ProductNDC>60219-1158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 80</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1310-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1310-9) </PackageDescription>
    <NDC11Code>60219-1310-09</NDC11Code>
    <ProductNDC>60219-1310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1311-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1311-9) </PackageDescription>
    <NDC11Code>60219-1311-09</NDC11Code>
    <ProductNDC>60219-1311</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1312-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1312-9) </PackageDescription>
    <NDC11Code>60219-1312-09</NDC11Code>
    <ProductNDC>60219-1312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1313-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1313-9) </PackageDescription>
    <NDC11Code>60219-1313-09</NDC11Code>
    <ProductNDC>60219-1313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1314-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1314-9) </PackageDescription>
    <NDC11Code>60219-1314-09</NDC11Code>
    <ProductNDC>60219-1314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1315-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1315-9) </PackageDescription>
    <NDC11Code>60219-1315-09</NDC11Code>
    <ProductNDC>60219-1315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1316-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1316-9) </PackageDescription>
    <NDC11Code>60219-1316-09</NDC11Code>
    <ProductNDC>60219-1316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1317-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1317-9) </PackageDescription>
    <NDC11Code>60219-1317-09</NDC11Code>
    <ProductNDC>60219-1317</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209743</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1421-9</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (60219-1421-9) </PackageDescription>
    <NDC11Code>60219-1421-09</NDC11Code>
    <ProductNDC>60219-1421</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1640-8</NDCCode>
    <PackageDescription>3 BOTTLE, PLASTIC in 1 CARTON (60219-1640-8)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-1640-9) </PackageDescription>
    <NDC11Code>60219-1640-08</NDC11Code>
    <ProductNDC>60219-1640</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212570</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone, USP belongs to the chemical class of pyridone. Pirfenidone tablets, USP are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone, USP has a molecular formula of C12H11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone, USP is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Pirfenidone Tablets, USP are available for oral administration, each pirfenidone tablet, USP contains pirfenidone USP, 267 mg or 801 mg, as active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (801 mg), hypromellose, iron oxide red (801 mg), iron oxide yellow (267 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1641-9</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1641-9)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1641-09</NDC11Code>
    <ProductNDC>60219-1641</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212570</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>801</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone, USP belongs to the chemical class of pyridone. Pirfenidone tablets, USP are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone, USP has a molecular formula of C12H11NO and a molecular weight of 185.22 g/mol. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone, USP is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Pirfenidone Tablets, USP are available for oral administration, each pirfenidone tablet, USP contains pirfenidone USP, 267 mg or 801 mg, as active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (801 mg), hypromellose, iron oxide red (801 mg), iron oxide yellow (267 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2009-9</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9) </PackageDescription>
    <NDC11Code>60219-2009-09</NDC11Code>
    <ProductNDC>60219-2009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tiopronin</ProprietaryName>
    <NonProprietaryName>Tiopronin</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216278</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIOPRONIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s THIOLA EC (tiopronin) delayed-release tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:. Tiopronin has the molecular formula C5H9NO3S and a molecular weight of 163.19 g/mol. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white color crystalline powder, which is freely soluble in water. Each tiopronin delayed-release tablet contains 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid and ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate. Each tablet is imprinted with red pharmaceutical ink which contains: alcohol, butyl alcohol, FD &amp; C Red # 40, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-5511-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-5511-9) </PackageDescription>
    <NDC11Code>60219-5511-09</NDC11Code>
    <ProductNDC>60219-5511</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076509</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>54</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-­C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. (1.1), 2 For treatment of adult patients with severe hypertriglyceridemia. (1.2).</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83 g/mol; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, NF; hypromellose, USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose, macrogol, polydextrose, titanium dioxide and triacetin. In addition, the 54 mg strength film-coating material also contains D&amp;C Yellow No. 10 Aluminum Lake and FD&amp;C Yellow # 6/Sunset yellow FCF aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-5522-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-5522-9) </PackageDescription>
    <NDC11Code>60219-5522-09</NDC11Code>
    <ProductNDC>60219-5522</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076509</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-­C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. (1.1), 2 For treatment of adult patients with severe hypertriglyceridemia. (1.2).</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83 g/mol; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains croscarmellose sodium, NF; hypromellose, USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose, macrogol, polydextrose, titanium dioxide and triacetin. In addition, the 54 mg strength film-coating material also contains D&amp;C Yellow No. 10 Aluminum Lake and FD&amp;C Yellow # 6/Sunset yellow FCF aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1420-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0832-1420-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00832-1420-05</NDC11Code>
    <ProductNDC>0832-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216772</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (for topical ophthalmic use). The structural formula of brimonidine tartrate is. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In a solution brimonidine tartrate has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 6.9 to 7.4. Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.15% (1.5 mg/mL) with the inactive ingredients: sodium carboxymethylcellulose, sodium borate, boric acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, stabilized oxychloro complex 0.005% (0.05 mg/mL) as a preservative, purified water, hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1420-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0832-1420-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00832-1420-10</NDC11Code>
    <ProductNDC>0832-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216772</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (for topical ophthalmic use). The structural formula of brimonidine tartrate is. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In a solution brimonidine tartrate has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 6.9 to 7.4. Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.15% (1.5 mg/mL) with the inactive ingredients: sodium carboxymethylcellulose, sodium borate, boric acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, stabilized oxychloro complex 0.005% (0.05 mg/mL) as a preservative, purified water, hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1420-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0832-1420-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00832-1420-15</NDC11Code>
    <ProductNDC>0832-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216772</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (for topical ophthalmic use). The structural formula of brimonidine tartrate is. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In a solution brimonidine tartrate has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 6.9 to 7.4. Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.15% (1.5 mg/mL) with the inactive ingredients: sodium carboxymethylcellulose, sodium borate, boric acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, stabilized oxychloro complex 0.005% (0.05 mg/mL) as a preservative, purified water, hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-1420-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1420-2) </PackageDescription>
    <NDC11Code>22840-1420-02</NDC11Code>
    <ProductNDC>22840-1420</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Oregon Ash Pollen</ProprietaryName>
    <NonProprietaryName>Fraxinus Latifolia</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>FRAXINUS LATIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-1420-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1420-4) </PackageDescription>
    <NDC11Code>22840-1420-04</NDC11Code>
    <ProductNDC>22840-1420</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Oregon Ash Pollen</ProprietaryName>
    <NonProprietaryName>Fraxinus Latifolia</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>FRAXINUS LATIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
    <Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>43742-1420-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1420-1) </PackageDescription>
    <NDC11Code>43742-1420-01</NDC11Code>
    <ProductNDC>43742-1420</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Healing Support</ProprietaryName>
    <NonProprietaryName>Betula (pendula) Cortex, Caltha Palustris, Galium Aparine, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (angustifolia), Argentum Metallicum, Calcarea Fluorica, Nitricum Acidum, Sedum Acre, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190110</StartMarketingDate>
    <EndMarketingDate>20250820</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Deseret Biologicals, Inc.</LabelerName>
    <SubstanceName>APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GARLIC; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS</SubstanceName>
    <StrengthNumber>12; 1; 8; 3; 4; 5; 3; 6; 4; 4; 8; 5; 9; 12; 8; 4; 8; 3; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190110</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250820</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of symptoms related to muscle and joint pain, fever, chills, nose and sinus congestion, irritated throat, and gastrointestinal discomfort.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51662-1420-1</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (51662-1420-1)  / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>51662-1420-01</NDC11Code>
    <ProductNDC>51662-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nalbuphine Hci</ProprietaryName>
    <NonProprietaryName>Nalbuphine Hci</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20191029</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070915</ApplicationNumber>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>NALBUPHINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191029</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL at 25°C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4 ∙ HCl. The structural formula is. Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, dihydrate 0.47 mg and citric acid, anhydrous 0.63 mg added as buffers and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5). Contains sodium chloride for tonicity adjustment. Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Single-dose products contain no bacteriostat or antimicrobial agent and unused portions must be discarded.</Description>
  </NDC>
  <NDC>
    <NDCCode>67046-1420-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1420-3) </PackageDescription>
    <NDC11Code>67046-1420-03</NDC11Code>
    <ProductNDC>67046-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077859</ApplicationNumber>
    <LabelerName>Coupler LLC</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: : 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
    <Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3­-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
</NDCList>