RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>62332-479-64</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (62332-479-64)  / 90 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>62332-0479-64</NDC11Code>
    <ProductNDC>62332-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-479-27</NDCCode>
    <PackageDescription>270 TABLET, COATED in 1 BOTTLE (62332-479-27) </PackageDescription>
    <NDC11Code>62332-0479-27</NDC11Code>
    <ProductNDC>62332-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-479-71</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (62332-479-71) </PackageDescription>
    <NDC11Code>62332-0479-71</NDC11Code>
    <ProductNDC>62332-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-479-64</NDCCode>
    <PackageDescription>3 BOTTLE in 1 CARTON (46708-479-64)  / 90 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>46708-0479-64</NDC11Code>
    <ProductNDC>46708-479</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pirfenidone</ProprietaryName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212708</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>267</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
    <Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (267 mg) and ferrosoferric oxide (801 mg), iron oxide red (801 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>69168-479-64</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69168-479-64)  / 60 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>69168-0479-64</NDC11Code>
    <ProductNDC>69168-479</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250502</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216421</ApplicationNumber>
    <LabelerName>Allegiant Health</LabelerName>
    <SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>205.5</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 runny nose, 4 itchy nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62332-022-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (62332-022-30) </PackageDescription>
    <NDC11Code>62332-0022-30</NDC11Code>
    <ProductNDC>62332-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-022-31</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (62332-022-31) </PackageDescription>
    <NDC11Code>62332-0022-31</NDC11Code>
    <ProductNDC>62332-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-022-71</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (62332-022-71) </PackageDescription>
    <NDC11Code>62332-0022-71</NDC11Code>
    <ProductNDC>62332-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-022-91</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (62332-022-91) </PackageDescription>
    <NDC11Code>62332-0022-91</NDC11Code>
    <ProductNDC>62332-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-023-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (62332-023-30) </PackageDescription>
    <NDC11Code>62332-0023-30</NDC11Code>
    <ProductNDC>62332-023</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
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  <NDC>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
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  <NDC>
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    <PackageDescription>500 CAPSULE in 1 BOTTLE (62332-023-71) </PackageDescription>
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    <ProductNDC>62332-023</ProductNDC>
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    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <LastUpdate>2025-03-24</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
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  <NDC>
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    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
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  <NDC>
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    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-024-31</NDCCode>
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    <ProductNDC>62332-024</ProductNDC>
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    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
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    <ProductNDC>62332-024</ProductNDC>
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    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
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    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-024-91</NDCCode>
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    <ProductNDC>62332-024</ProductNDC>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090223</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for  Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain lactose monohydrate, microcrystalline cellulose, colloidal silicone dioxide, gelatin, titanium dioxide, FD &amp; C Blue No. 1 and FD &amp; C Red No. 40.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-077-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-077-30) </PackageDescription>
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    <ProductNDC>62332-077</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prucalopride</ProprietaryName>
    <NonProprietaryName>Prucalopride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219234</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
    <Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to off-white powder. It is freely soluble in 0.1N HCl and soluble in N, N-Dimethyl formamide, sparingly soluble in methanol, practically insoluble in ethyl acetate. Each 1-mg film-coated prucalopride tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: cellulose powder, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The coating material contains hypromellose, polyethylene glycol 400 and titanium dioxide. Each 2-mg film-coated prucalopride tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: cellulose powder, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The coating material contains ferrosoferric oxide, hypromellose, iron oxide red, polyethylene glycol 400 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-078-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-078-30) </PackageDescription>
    <NDC11Code>62332-0078-30</NDC11Code>
    <ProductNDC>62332-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prucalopride</ProprietaryName>
    <NonProprietaryName>Prucalopride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219234</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
    <Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to off-white powder. It is freely soluble in 0.1N HCl and soluble in N, N-Dimethyl formamide, sparingly soluble in methanol, practically insoluble in ethyl acetate. Each 1-mg film-coated prucalopride tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: cellulose powder, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The coating material contains hypromellose, polyethylene glycol 400 and titanium dioxide. Each 2-mg film-coated prucalopride tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: cellulose powder, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. The coating material contains ferrosoferric oxide, hypromellose, iron oxide red, polyethylene glycol 400 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-242-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-242-30) </PackageDescription>
    <NDC11Code>62332-0242-30</NDC11Code>
    <ProductNDC>62332-242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-242-31</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62332-242-31) </PackageDescription>
    <NDC11Code>62332-0242-31</NDC11Code>
    <ProductNDC>62332-242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-242-91</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (62332-242-91) </PackageDescription>
    <NDC11Code>62332-0242-91</NDC11Code>
    <ProductNDC>62332-242</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-243-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-243-30) </PackageDescription>
    <NDC11Code>62332-0243-30</NDC11Code>
    <ProductNDC>62332-243</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-243-31</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62332-243-31) </PackageDescription>
    <NDC11Code>62332-0243-31</NDC11Code>
    <ProductNDC>62332-243</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-243-91</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (62332-243-91) </PackageDescription>
    <NDC11Code>62332-0243-91</NDC11Code>
    <ProductNDC>62332-243</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208698</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).</IndicationAndUsage>
    <Description>Fluoxetine (fluoxetine tablets, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder, it is freely soluble in alcohol and in methanol, sparingly soluble in water and in dichloromethane, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, corn starch, hypromellose, crospovidone, magnesium stearate, colloidal silicon dioxide, titanium dioxide and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-777-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (62332-777-01)  / 1 mL in 1 VIAL</PackageDescription>
    <NDC11Code>62332-0777-01</NDC11Code>
    <ProductNDC>62332-777</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217198</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine injection sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion. 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.</IndicationAndUsage>
    <Description>Carboprost tromethamine injection, USP is a sterile solution, an oxytocic, contains the tromethamine salt of the (15S)­-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are. 1. (15S)-15-methyl prostaglandin F2α tromethamine salt 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α­-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)­1,3-propanediol 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt 4. (15S)-15-methyl PGF2α-THAM. The structural formula is represented below. The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105°C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-777-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (62332-777-10)  / 1 mL in 1 VIAL</PackageDescription>
    <NDC11Code>62332-0777-10</NDC11Code>
    <ProductNDC>62332-777</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carboprost Tromethamine</ProprietaryName>
    <NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217198</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carboprost tromethamine injection sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion. 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.</IndicationAndUsage>
    <Description>Carboprost tromethamine injection, USP is a sterile solution, an oxytocic, contains the tromethamine salt of the (15S)­-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are. 1. (15S)-15-methyl prostaglandin F2α tromethamine salt 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α­-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)­1,3-propanediol 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt 4. (15S)-15-methyl PGF2α-THAM. The structural formula is represented below. The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105°C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-6902-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (0002-6902-30) </PackageDescription>
    <NDC11Code>00002-6902-30</NDC11Code>
    <ProductNDC>0002-6902</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jaypirca</ProprietaryName>
    <NonProprietaryName>Pirtobrutinib</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216059</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>PIRTOBRUTINIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Bruton's Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JAYPIRCA® is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (1.1).This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. , 2 Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (1.2).</IndicationAndUsage>
    <Description>Pirtobrutinib is a kinase inhibitor. It is an orally available, small molecule ATP-competitive inhibitor of BTK. The active pharmaceutical ingredient is pirtobrutinib with the molecular formula C22H21F4N5O3 and a molecular weight of 479.44 g/mol. The chemical name for pirtobrutinib is 5-amino-3-{4-[(5-fluoro-2-methoxybenzamido)methyl]phenyl}-1-[(2S)-1,1,1-trifluoropropan-2-yl]-1H-pyrazole-4-carboxamide. Pirtobrutinib is a white to practically white to yellow to brown solid. The aqueous solubility of pirtobrutinib is considered practically insoluble, or insoluble, across the pH 1 to pH 7 range. Pirtobrutinib tablets are supplied as 50 mg or 100 mg film-coated, debossed tablets for oral administration. Each tablet contains inactive ingredients of croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide. The tablet film coating material contains FD&amp;C Blue #2, hypromellose, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-7026-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (0002-7026-60) </PackageDescription>
    <NDC11Code>00002-7026-60</NDC11Code>
    <ProductNDC>0002-7026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jaypirca</ProprietaryName>
    <NonProprietaryName>Pirtobrutinib</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216059</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>PIRTOBRUTINIB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Bruton's Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JAYPIRCA® is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (1.1).This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. , 2 Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (1.2).</IndicationAndUsage>
    <Description>Pirtobrutinib is a kinase inhibitor. It is an orally available, small molecule ATP-competitive inhibitor of BTK. The active pharmaceutical ingredient is pirtobrutinib with the molecular formula C22H21F4N5O3 and a molecular weight of 479.44 g/mol. The chemical name for pirtobrutinib is 5-amino-3-{4-[(5-fluoro-2-methoxybenzamido)methyl]phenyl}-1-[(2S)-1,1,1-trifluoropropan-2-yl]-1H-pyrazole-4-carboxamide. Pirtobrutinib is a white to practically white to yellow to brown solid. The aqueous solubility of pirtobrutinib is considered practically insoluble, or insoluble, across the pH 1 to pH 7 range. Pirtobrutinib tablets are supplied as 50 mg or 100 mg film-coated, debossed tablets for oral administration. Each tablet contains inactive ingredients of croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide. The tablet film coating material contains FD&amp;C Blue #2, hypromellose, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0002-7026-99</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (0002-7026-99) </PackageDescription>
    <NDC11Code>00002-7026-99</NDC11Code>
    <ProductNDC>0002-7026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Jaypirca</ProprietaryName>
    <NonProprietaryName>Pirtobrutinib</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216059</ApplicationNumber>
    <LabelerName>Eli Lilly and Company</LabelerName>
    <SubstanceName>PIRTOBRUTINIB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Bruton's Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230215</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>JAYPIRCA® is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (1.1).This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. , 2 Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (1.2).</IndicationAndUsage>
    <Description>Pirtobrutinib is a kinase inhibitor. It is an orally available, small molecule ATP-competitive inhibitor of BTK. The active pharmaceutical ingredient is pirtobrutinib with the molecular formula C22H21F4N5O3 and a molecular weight of 479.44 g/mol. The chemical name for pirtobrutinib is 5-amino-3-{4-[(5-fluoro-2-methoxybenzamido)methyl]phenyl}-1-[(2S)-1,1,1-trifluoropropan-2-yl]-1H-pyrazole-4-carboxamide. Pirtobrutinib is a white to practically white to yellow to brown solid. The aqueous solubility of pirtobrutinib is considered practically insoluble, or insoluble, across the pH 1 to pH 7 range. Pirtobrutinib tablets are supplied as 50 mg or 100 mg film-coated, debossed tablets for oral administration. Each tablet contains inactive ingredients of croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide. The tablet film coating material contains FD&amp;C Blue #2, hypromellose, titanium dioxide and triacetin.</Description>
  </NDC>
</NDCList>