RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>31722-258-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (31722-258-28) </PackageDescription>
    <NDC11Code>31722-0258-28</NDC11Code>
    <ProductNDC>31722-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212414</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:  Multiple myeloma (MM), in combination with dexamethasone ( 1.1).  MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1).   Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2).  Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3).   Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4).   Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). Limitations of Use:  Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4).</IndicationAndUsage>
    <Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale-yellow powder. It is slightly soluble in dimethyl formamide. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.  Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, in addition 2.5 mg, 15 mg, and 20 mg contains iron oxide red, 10 mg contains FD&amp;C Yellow 6, 20 mg contains iron oxide yellow and iron oxide black. The capsules are imprinted with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-258-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (31722-258-01) </PackageDescription>
    <NDC11Code>31722-0258-01</NDC11Code>
    <ProductNDC>31722-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212414</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:  Multiple myeloma (MM), in combination with dexamethasone ( 1.1).  MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1).   Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2).  Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3).   Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4).   Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). Limitations of Use:  Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4).</IndicationAndUsage>
    <Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale-yellow powder. It is slightly soluble in dimethyl formamide. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.  Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, in addition 2.5 mg, 15 mg, and 20 mg contains iron oxide red, 10 mg contains FD&amp;C Yellow 6, 20 mg contains iron oxide yellow and iron oxide black. The capsules are imprinted with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>11383-258-51</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11383-258-51)  &gt; 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>11383-0258-51</NDC11Code>
    <ProductNDC>11383-258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Weeks And Leo Extra Strength Itch Stopping</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride And Zinc Acetate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140317</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Weeks &amp; Leo Co., Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
    <StrengthNumber>20; 1</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>temporarliy relieves pain and itching due to: 1 insect bites, 2 minor burns, 3 sunburn, 4 minor skin irritations, 5 minor cuts, 6 scrapes, 7 rashes due to poison ivy, poison oak, and poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24236-258-28</NDCCode>
    <PackageDescription>300 TABLET, SUGAR COATED in 1 CANISTER (24236-258-28)</PackageDescription>
    <NDC11Code>24236-0258-28</NDC11Code>
    <ProductNDC>24236-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA084114</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>53943-258-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (53943-258-01)  / 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>53943-0258-01</NDC11Code>
    <ProductNDC>53943-258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Discount Drug Mart Extra Strength Itch Stopping</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride And Zinc Acetate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140317</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Discount Drug Mart</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
    <StrengthNumber>20; 1</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarliy relieves pain and itching due to: 1 insect bites, 2 minor burns, 3 sunburn, 4 minor skin irritations, 5 minor cuts, 6 scrapes, 7 rashes due to poison ivy, poison oak, and poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-257-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (31722-257-28) </PackageDescription>
    <NDC11Code>31722-0257-28</NDC11Code>
    <ProductNDC>31722-257</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212414</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:  Multiple myeloma (MM), in combination with dexamethasone ( 1.1).  MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1).   Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2).  Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3).   Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4).   Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). Limitations of Use:  Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4).</IndicationAndUsage>
    <Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale-yellow powder. It is slightly soluble in dimethyl formamide. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.  Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, in addition 2.5 mg, 15 mg, and 20 mg contains iron oxide red, 10 mg contains FD&amp;C Yellow 6, 20 mg contains iron oxide yellow and iron oxide black. The capsules are imprinted with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-259-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (31722-259-28) </PackageDescription>
    <NDC11Code>31722-0259-28</NDC11Code>
    <ProductNDC>31722-259</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212414</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:  Multiple myeloma (MM), in combination with dexamethasone ( 1.1).  MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1).   Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2).  Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3).   Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4).   Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). Limitations of Use:  Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4).</IndicationAndUsage>
    <Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3, and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale-yellow powder. It is slightly soluble in dimethyl formamide. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.  Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, in addition 2.5 mg, 15 mg, and 20 mg contains iron oxide red, 10 mg contains FD&amp;C Yellow 6, 20 mg contains iron oxide yellow and iron oxide black. The capsules are imprinted with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-676-36</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (31722-676-36)  / 28 TABLET in 1 BLISTER PACK (31722-676-35) </PackageDescription>
    <NDC11Code>31722-0676-36</NDC11Code>
    <ProductNDC>31722-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Roflumilast</ProprietaryName>
    <NonProprietaryName>Roflumilast</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230418</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208213</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ROFLUMILAST</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Roflumilast tablet is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
    <Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is 3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy) benzamide.  Its empirical formula is C 17H 14C l2F 2N 2O 3 and the molecular weight is 403.21. The chemical structure is:. The drug substance is a light brown to white color powder with a melting point of 154 to 160°C. It is soluble in acetone and slightly soluble in ethanol. Roflumilast tablets are supplied as white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and 'T' (for 250 mcg), and 'I' (for 500 mcg) on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of roflumilast for oral administration contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-779-33</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (31722-779-33)  / 28 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>31722-0779-33</NDC11Code>
    <ProductNDC>31722-779</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nilotinib</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209651</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NILOTINIB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nilotinib is a kinase inhibitor indicated for the treatment of:  Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1)  Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2)  Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3).</IndicationAndUsage>
    <Description>Nilotinib capsules contain nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, a dihydrate mono hydrochloride, is a slightly yellow to slightly greenish yellow powder with the molecular formula C 28H 22F 3N 7O. HCI. 2H 2O and relative molecular mass of 602.02. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a1 was determined to be 2.1; pK a2 was estimated to be 5.4. The chemical name of nilotinib is 4-Methyl-N-[3-4-methyl-1 H imidazole-1-yl)-5- (trifluoromethyl) phenyl]-3-[[4-pyridin-3-ylpyrimidin-2yl] amino] benzamide hydrochloride dihydrate. Its structure is shown below:. Nilotinib capsules, for oral use, contain 150 mg or 200 mg nilotinib base, (equivalent to 170.535 mg and 227.380 mg nilotinib hydrochloride, dihydrate) with the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. In addition, the 150 mg capsule also contains iron oxide red.  The imprinting ink contains shellac, propylene glycol, strong ammonia solution. The 150 mg capsules also contain potassium hydroxide and iron oxide black. The 200 mg capsules also contain iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-780-33</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (31722-780-33)  / 28 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>31722-0780-33</NDC11Code>
    <ProductNDC>31722-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nilotinib</ProprietaryName>
    <NonProprietaryName>Nilotinib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209651</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NILOTINIB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nilotinib is a kinase inhibitor indicated for the treatment of:  Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1)  Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2)  Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3).</IndicationAndUsage>
    <Description>Nilotinib capsules contain nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, a dihydrate mono hydrochloride, is a slightly yellow to slightly greenish yellow powder with the molecular formula C 28H 22F 3N 7O. HCI. 2H 2O and relative molecular mass of 602.02. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a1 was determined to be 2.1; pK a2 was estimated to be 5.4. The chemical name of nilotinib is 4-Methyl-N-[3-4-methyl-1 H imidazole-1-yl)-5- (trifluoromethyl) phenyl]-3-[[4-pyridin-3-ylpyrimidin-2yl] amino] benzamide hydrochloride dihydrate. Its structure is shown below:. Nilotinib capsules, for oral use, contain 150 mg or 200 mg nilotinib base, (equivalent to 170.535 mg and 227.380 mg nilotinib hydrochloride, dihydrate) with the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. In addition, the 150 mg capsule also contains iron oxide red.  The imprinting ink contains shellac, propylene glycol, strong ammonia solution. The 150 mg capsules also contain potassium hydroxide and iron oxide black. The 200 mg capsules also contain iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-935-28</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (31722-935-28) </PackageDescription>
    <NDC11Code>31722-0935-28</NDC11Code>
    <ProductNDC>31722-935</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albendazole</ProprietaryName>
    <ProprietaryNameSuffix>200 Mg</ProprietaryNameSuffix>
    <NonProprietaryName>Albendazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210011</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals</LabelerName>
    <SubstanceName>ALBENDAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albendazole tablets are an anthelmintic drug indicated for.  Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.  (1.1).  Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. (1.2).</IndicationAndUsage>
    <Description>Albendazole Tablets, USP are an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole, USP is practically insoluble in alcohol and in water. Each white to off-white round, biconvex, film coated tablets with "V 32" debossed on one side and plain on other side. Inactive ingredients consist of: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-945-31</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (31722-945-31)  / 1 KIT in 1 BLISTER PACK (31722-945-28) </PackageDescription>
    <NDC11Code>31722-0945-31</NDC11Code>
    <ProductNDC>31722-945</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Drospirenone And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20200124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213034</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Drospirenone and ethinyl estradiol tablets are use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Drospirenone and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:  21 yellow tablets each contains 3 mg DRSP and 0.03 mg EE  7 inert white tablets The inactive ingredients in the yellow tablets are corn starch, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (maize), talc and titanium dioxide. The white inert film-coated tablets contain magnesium stearate, microcrystalline cellulose, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Drospirenone(6 R,7 R,8 R,9 S,10 R,13 S,14 S,15 S,16 S,17 S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-Hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5’ H)-furan]-3,5’(2 H)-dione is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C 24H 30O 3. Ethinyl estradiol 19-Nor-17α-pregna-1,3,5(10)-triene-20-yne-3,17β-diol is a synthetic estrogenic compound and has a molecular weight of 296.41 and a molecular formula of C 20H 24O 2. The structural formulas are as follows:. Drospirenone.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-945-32</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (31722-945-32)  / 1 KIT in 1 BLISTER PACK (31722-945-28) </PackageDescription>
    <NDC11Code>31722-0945-32</NDC11Code>
    <ProductNDC>31722-945</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Drospirenone And Ethinyl Estradiol</ProprietaryName>
    <NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20200124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213034</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-09-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Drospirenone and ethinyl estradiol tablets are use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>Drospirenone and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:  21 yellow tablets each contains 3 mg DRSP and 0.03 mg EE  7 inert white tablets The inactive ingredients in the yellow tablets are corn starch, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch (maize), talc and titanium dioxide. The white inert film-coated tablets contain magnesium stearate, microcrystalline cellulose, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Drospirenone(6 R,7 R,8 R,9 S,10 R,13 S,14 S,15 S,16 S,17 S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-Hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5’ H)-furan]-3,5’(2 H)-dione is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C 24H 30O 3. Ethinyl estradiol 19-Nor-17α-pregna-1,3,5(10)-triene-20-yne-3,17β-diol is a synthetic estrogenic compound and has a molecular weight of 296.41 and a molecular formula of C 20H 24O 2. The structural formulas are as follows:. Drospirenone.</Description>
  </NDC>
  <NDC>
    <NDCCode>51862-258-00</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (51862-258-00)  / 1 KIT in 1 BLISTER PACK *  24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24)  *  4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) </PackageDescription>
    <NDC11Code>51862-0258-00</NDC11Code>
    <ProductNDC>51862-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nextstellis</ProprietaryName>
    <NonProprietaryName>Drospirenone And Estetrol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210416</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214154</ApplicationNumber>
    <LabelerName>Mayne Pharma</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210416</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>NEXTSTELLIS® (drospirenone and estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister card containing 28 tablets: 1 24 pink active tablets contain 3 mg drospirenone and 14.2 mg of estetrol on the anhydrous basis. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen., 2 4 white inert tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>51862-258-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (51862-258-01)  / 1 KIT in 1 BLISTER PACK *  24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24)  *  4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) </PackageDescription>
    <NDC11Code>51862-0258-01</NDC11Code>
    <ProductNDC>51862-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nextstellis</ProprietaryName>
    <NonProprietaryName>Drospirenone And Estetrol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210416</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214154</ApplicationNumber>
    <LabelerName>Mayne Pharma</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
    <Description>NEXTSTELLIS® (drospirenone and estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister card containing 28 tablets: 1 24 pink active tablets contain 3 mg drospirenone and 14.2 mg of estetrol on the anhydrous basis. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen., 2 4 white inert tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>57687-258-20</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE, DROPPER (57687-258-20) </PackageDescription>
    <NDC11Code>57687-0258-20</NDC11Code>
    <ProductNDC>57687-258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bach Original Flower Remedies</ProprietaryName>
    <NonProprietaryName>Clematis Vitalba Top</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nelson Bach USA Limited</LabelerName>
    <SubstanceName>CLEMATIS VITALBA TOP</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>[hp_X]/.095mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2020-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For relief of naturally occurring simple nervous tension.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59572-205-94</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BOX (59572-205-94)  / 28 CAPSULE in 1 BLISTER PACK (59572-205-14) </PackageDescription>
    <NDC11Code>59572-0205-94</NDC11Code>
    <ProductNDC>59572-205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thalomid</ProprietaryName>
    <NonProprietaryName>Thalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030620</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020785</ApplicationNumber>
    <LabelerName>Celgene Corporation</LabelerName>
    <SubstanceName>THALIDOMIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Immunologically Active Molecule Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).</IndicationAndUsage>
    <Description>THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&amp;C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&amp;C blue #2, titanium dioxide, gelatin, and white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>59572-210-95</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 BOX (59572-210-95)  / 28 CAPSULE in 1 BLISTER PACK (59572-210-15) </PackageDescription>
    <NDC11Code>59572-0210-95</NDC11Code>
    <ProductNDC>59572-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thalomid</ProprietaryName>
    <NonProprietaryName>Thalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030620</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020785</ApplicationNumber>
    <LabelerName>Celgene Corporation</LabelerName>
    <SubstanceName>THALIDOMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Immunologically Active Molecule Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).</IndicationAndUsage>
    <Description>THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&amp;C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&amp;C blue #2, titanium dioxide, gelatin, and white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>59572-215-93</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 BOX (59572-215-93)  / 28 CAPSULE in 1 BLISTER PACK (59572-215-13) </PackageDescription>
    <NDC11Code>59572-0215-93</NDC11Code>
    <ProductNDC>59572-215</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thalomid</ProprietaryName>
    <NonProprietaryName>Thalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070320</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020785</ApplicationNumber>
    <LabelerName>Celgene Corporation</LabelerName>
    <SubstanceName>THALIDOMIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Immunologically Active Molecule Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).</IndicationAndUsage>
    <Description>THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&amp;C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&amp;C blue #2, titanium dioxide, gelatin, and white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>59572-220-96</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 BOX (59572-220-96)  / 28 CAPSULE in 1 BLISTER PACK (59572-220-16) </PackageDescription>
    <NDC11Code>59572-0220-96</NDC11Code>
    <ProductNDC>59572-220</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thalomid</ProprietaryName>
    <NonProprietaryName>Thalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030620</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020785</ApplicationNumber>
    <LabelerName>Celgene Corporation</LabelerName>
    <SubstanceName>THALIDOMIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Immunologically Active Molecule Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).</IndicationAndUsage>
    <Description>THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&amp;C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&amp;C blue #2, titanium dioxide, gelatin, and white ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-258-03</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01) </PackageDescription>
    <NDC11Code>63323-0258-03</NDC11Code>
    <ProductNDC>63323-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20041130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040583</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection sterile powder is indicated as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>Methylprednisolone Sodium Succinate for Injection, USP sterile powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β). The structural formula is represented below:. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone Sodium Succinate for Injection, USP is available in three strengths for intravenous or intramuscular administration. 40 mg (Single-Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried and 25 mg lactose hydrous; and benzyl alcohol. 125 mg (Single-Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol. 1 g (Multiple Dose Vial ) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium phosphate dried; and benzyl alcohol. IMPORTANT- Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting Methylprednisolone Sodium Succinate for Injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 g per 16 mL solution is 0.40 osmolar. (Isotonic saline = 0.28 osmolar).</Description>
  </NDC>
  <NDC>
    <NDCCode>69842-258-01</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX (69842-258-01)  &gt; 100 mL in 1 VIAL</PackageDescription>
    <NDC11Code>69842-0258-01</NDC11Code>
    <ProductNDC>69842-258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants Pain And Fever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181228</StartMarketingDate>
    <EndMarketingDate>20240228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> reduces fever.  relieves minor aches and pains due to.  the common cold  flu  headache  sore throat  toothache.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70954-258-10</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (70954-258-10) </PackageDescription>
    <NDC11Code>70954-0258-10</NDC11Code>
    <ProductNDC>70954-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214330</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>200; 40</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystisjirovecii Pneumonia: For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.  jirovecii pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
    <Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in a suspension for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white crystalline powder with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to cream colored crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, sorbitol, FD&amp;C Red No. 40, simethicone and artificial cherry flavor (corn maltodextrin, artificial flavor and modified corn starch).</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-900-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-900-01)  &gt; 10 mL in 1 VIAL, GLASS (76125-900-02) </PackageDescription>
    <NDC11Code>76125-0900-01</NDC11Code>
    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMMAKED is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMMAKED manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-900-10</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-900-10)  &gt; 100 mL in 1 VIAL, GLASS (76125-900-11) </PackageDescription>
    <NDC11Code>76125-0900-10</NDC11Code>
    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMMAKED is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMMAKED manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-900-20</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-900-20)  &gt; 200 mL in 1 VIAL, GLASS (76125-900-21) </PackageDescription>
    <NDC11Code>76125-0900-20</NDC11Code>
    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMMAKED is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMMAKED manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
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    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMMAKED is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMMAKED manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>76125-900-50</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (76125-900-50)  &gt; 50 mL in 1 VIAL, GLASS (76125-900-51) </PackageDescription>
    <NDC11Code>76125-0900-50</NDC11Code>
    <ProductNDC>76125-900</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Gammaked</ProprietaryName>
    <NonProprietaryName>Immune Globulin (human)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20101013</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125046</ApplicationNumber>
    <LabelerName>KEDRION BIOPHARMA, INC.</LabelerName>
    <SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GAMMAKED is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:.</IndicationAndUsage>
    <Description>GAMMAKED is a ready-to-use sterile, non-pyrogenic solution of human immune globulin protein for intravenous and subcutaneous (PI indication only) administration. GAMMAKED is clear to opalescent, and colorless to pale yellow. GAMMAKED consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. The main component of GAMMAKED is IgG (≥ 98%) with a sub-class distribution of IgG1, IgG2, IgG3 and IgG4 of approximately 62.8%, 29.7%, 4.8% and 2.7% respectively. The distribution of IgG subclasses is similar to that found in normal serum. GAMMAKED contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. GAMMAKED doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported, the doses and rates of administration were 3–4 fold greater than those for GAMMAKED. In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects.(21) Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects.(22) Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L). The measured buffer capacity is 35 mEq/L (0.35 mEq/g protein) and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMMAKED would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously. The pH of GAMMAKED is 4.0–4.5. GAMMAKED contains no preservative. GAMMAKED is not made with natural rubber latex. GAMMAKED is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMMAKED is incubated in the final container (at the low pH of 4.0–4.3). The product is intended for intravenous administration and may be administered subcutaneously in treatment of PI. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: human immunodeficiency virus, type I (HIV-1) as the relevant virus for HIV-1 and HIV–2; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for large enveloped DNA viruses (e.g., herpes viruses); Reovirus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation; hepatitis A virus (HAV) as relevant non-enveloped virus, and porcine parvovirus (PPV) as a model for human parvovirus B19.(23). Overall virus reduction was calculated only from steps that were mechanistically independent from each other and truly additive. In addition, each step was verified to provide robust virus reduction across the production range for key operating parameters. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(23). Several of the individual production steps in the GAMMAKED manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include two depth filtrations (in sequence, a total of ≥ 6.6 log10).  These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-005-30</NDCCode>
    <PackageDescription>5 PACKAGE in 1 CARTON (31722-005-30)  / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) </PackageDescription>
    <NDC11Code>31722-0005-30</NDC11Code>
    <ProductNDC>31722-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mesalamine</ProprietaryName>
    <NonProprietaryName>Mesalamine</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20200319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213377</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MESALAMINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.</IndicationAndUsage>
    <Description>The active ingredient in mesalamine 1,000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine rectal suppository contains 1,000 mg of mesalamine USP in a base of Hard Fat, NF. The molecular formula is C 7H 7NO 3, representing a molecular weight of 153.14. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-005-31</NDCCode>
    <PackageDescription>7 PACKAGE in 1 CARTON (31722-005-31)  / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) </PackageDescription>
    <NDC11Code>31722-0005-31</NDC11Code>
    <ProductNDC>31722-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mesalamine</ProprietaryName>
    <NonProprietaryName>Mesalamine</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20200319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213377</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MESALAMINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.</IndicationAndUsage>
    <Description>The active ingredient in mesalamine 1,000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine rectal suppository contains 1,000 mg of mesalamine USP in a base of Hard Fat, NF. The molecular formula is C 7H 7NO 3, representing a molecular weight of 153.14. The structural formula is:.</Description>
  </NDC>
</NDCList>