RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>58406-032-96</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58406-032-96)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>58406-0032-96</NDC11Code>
    <ProductNDC>58406-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58479-032-00</NDCCode>
    <PackageDescription>96 g in 1 CAN (58479-032-00)</PackageDescription>
    <NDC11Code>58479-0032-00</NDC11Code>
    <ProductNDC>58479-032</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kids Natural Mineral Sunscreen Broad Spectrum</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160117</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Crossing Cultures LLC dba Goddess Garden</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.4; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun.  .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58406-032-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-032-04)  / 1 mL in 1 SYRINGE (58406-032-01) </PackageDescription>
    <NDC11Code>58406-0032-04</NDC11Code>
    <ProductNDC>58406-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-032-90</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58406-032-90)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>58406-0032-90</NDC11Code>
    <ProductNDC>58406-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-010-96</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58406-010-96)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>58406-0010-96</NDC11Code>
    <ProductNDC>58406-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-021-96</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (58406-021-96)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>58406-0021-96</NDC11Code>
    <ProductNDC>58406-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-044-96</NDCCode>
    <PackageDescription>1 CARTRIDGE in 1 CARTON (58406-044-96)  / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>58406-0044-96</NDC11Code>
    <ProductNDC>58406-044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-055-96</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-96)  / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>58406-0055-96</NDC11Code>
    <ProductNDC>58406-055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200305</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200305</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>42893-032-00</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42893-032-00)  / 35 g in 1 TUBE</PackageDescription>
    <NDC11Code>42893-0032-00</NDC11Code>
    <ProductNDC>42893-032</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum Spf 15 Opaline</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Chantecaille Beaute Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>96.075</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-04-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44647-032-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (44647-032-10)  / 20 mL in 1 VIAL (44647-032-01) </PackageDescription>
    <NDC11Code>44647-0032-10</NDC11Code>
    <ProductNDC>44647-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160419</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206086</ApplicationNumber>
    <LabelerName>Savior Lifetec Corporation</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). ( 1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S∙3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>52565-032-12</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (52565-032-12)  &gt; 120 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>52565-0032-12</NDC11Code>
    <ProductNDC>52565-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciclopirox</ProprietaryName>
    <NonProprietaryName>Ciclopirox</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209975</ApplicationNumber>
    <LabelerName>Teligent Pharma, Inc.</LabelerName>
    <SubstanceName>CICLOPIROX</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.96mL</StrengthUnit>
    <Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciclopirox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.</IndicationAndUsage>
    <Description>Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate. Ciclopirox Shampoo is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
  </NDC>
  <NDC>
    <NDCCode>59078-032-01</NDCCode>
    <PackageDescription>50 g in 1 CARTON (59078-032-01)</PackageDescription>
    <NDC11Code>59078-0032-01</NDC11Code>
    <ProductNDC>59078-032</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bb Fit Perfect 24 Bb 02</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>TONYMOLY CO., LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.21; 1.5; .96</StrengthNumber>
    <StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-07</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60429-032-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (60429-032-01) </PackageDescription>
    <NDC11Code>60429-0032-01</NDC11Code>
    <ProductNDC>60429-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbamazepine</ProprietaryName>
    <NonProprietaryName>Carbamazepine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075948</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>CARBAMAZEPINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbamazepine tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
    <Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg.  Its chemical name is 5H-dibenzo[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white crystalline powder, very slightly soluble in water, freely soluble in methylene chloride, sparingly soluble in acetone and in ethanol (96 per cent). Its molecular weight is 236.3 g/mol. Carbamazepine tablets, USP 200 mg contain the active ingredient, carbamazepine USP, and the inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Carbamazepine tablets, 200 mg meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>71220-032-01</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (71220-032-01)  &gt; 14 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>71220-0032-01</NDC11Code>
    <ProductNDC>71220-032</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aqua Fit Cushion N23</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170623</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Innisfree Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>7; 1.66; 1.96</StrengthNumber>
    <StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58406-010-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-010-04)  / .5 mL in 1 SYRINGE (58406-010-01) </PackageDescription>
    <NDC11Code>58406-0010-04</NDC11Code>
    <ProductNDC>58406-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-021-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-021-04)  / 1 mL in 1 SYRINGE (58406-021-01) </PackageDescription>
    <NDC11Code>58406-0021-04</NDC11Code>
    <ProductNDC>58406-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-044-04</NDCCode>
    <PackageDescription>4 CARTRIDGE in 1 CARTON (58406-044-04)  / 1 mL in 1 CARTRIDGE (58406-044-01) </PackageDescription>
    <NDC11Code>58406-0044-04</NDC11Code>
    <ProductNDC>58406-044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-044-24</NDCCode>
    <PackageDescription>4 CARTRIDGE in 1 CARTON (58406-044-24)  / 1 mL in 1 CARTRIDGE (58406-044-01) </PackageDescription>
    <NDC11Code>58406-0044-24</NDC11Code>
    <ProductNDC>58406-044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-044-90</NDCCode>
    <PackageDescription>1 CARTRIDGE in 1 CARTON (58406-044-90)  / 1 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>58406-0044-90</NDC11Code>
    <ProductNDC>58406-044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190607</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190607</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-055-04</NDCCode>
    <PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-04)  / .5 mL in 1 VIAL, SINGLE-DOSE (58406-055-01) </PackageDescription>
    <NDC11Code>58406-0055-04</NDC11Code>
    <ProductNDC>58406-055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200305</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-055-90</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-90)  / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>58406-0055-90</NDC11Code>
    <ProductNDC>58406-055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20200305</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200305</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-425-34</NDCCode>
    <PackageDescription>4 KIT in 1 CARTON (58406-425-34)  / 1 KIT in 1 KIT (58406-425-41)  *  1 mL in 1 VIAL (58406-424-01)  *  1 mL in 1 SYRINGE (58406-910-01) </PackageDescription>
    <NDC11Code>58406-0425-34</NDC11Code>
    <ProductNDC>58406-425</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20030102</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-435-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-435-04)  / 1 mL in 1 SYRINGE (58406-435-01) </PackageDescription>
    <NDC11Code>58406-0435-04</NDC11Code>
    <ProductNDC>58406-435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20051006</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-445-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-445-04)  / 1 mL in 1 SYRINGE (58406-445-01) </PackageDescription>
    <NDC11Code>58406-0445-04</NDC11Code>
    <ProductNDC>58406-445</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20051110</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-446-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-446-04)  / 1 mL in 1 SYRINGE (58406-446-01) </PackageDescription>
    <NDC11Code>58406-0446-04</NDC11Code>
    <ProductNDC>58406-446</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20171020</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58406-455-04</NDCCode>
    <PackageDescription>4 SYRINGE in 1 CARTON (58406-455-04)  / .5 mL in 1 SYRINGE (58406-455-01) </PackageDescription>
    <NDC11Code>58406-0455-04</NDC11Code>
    <ProductNDC>58406-455</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20051110</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>58406-456-04</NDCCode>
    <PackageDescription>4 CARTRIDGE in 1 CARTON (58406-456-04)  / 1 mL in 1 CARTRIDGE (58406-456-01) </PackageDescription>
    <NDC11Code>58406-0456-04</NDC11Code>
    <ProductNDC>58406-456</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enbrel</ProprietaryName>
    <NonProprietaryName>Etanercept</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170929</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103795</ApplicationNumber>
    <LabelerName>Immunex Corporation</LabelerName>
    <SubstanceName>ETANERCEPT</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
    <Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0006-20</NDCCode>
    <PackageDescription>20 BAG in 1 CARTON (0338-0006-20)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-0006-20</NDC11Code>
    <ProductNDC>0338-0006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinephrine</ProprietaryName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260316</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218475</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinephrine in 0.9% Sodium Chloride Injection is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.1).</IndicationAndUsage>
    <Description>Epinephrine in Sodium Chloride injection contains active moiety, Epinephrine, a sympathomimetic catecholamine (adrenergic agent) in the form of Bitartrate salt. The chemical name of Epinephrine Bitartrate, USP, is 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). It is a white or greyish-white or light brownish-grey, odourless, crystalline powder, and slowly darkens on exposure to air and light. It has the following structural formula. The molecular weight of epinephrine bitartrate is 333.3 and molecular formula is C9H13NO3  C4H6O6. Epinephrine in 0.9% Sodium Chloride Injection is a clear, colorless sterile solution for intravenous administration, available in two strengths 4 mg/250 mL (16 mcg/mL) and 16 mg/250 mL (64 mcg/mL). The lower strength contains 4 mg (16 mcg epinephrine base per mL which is equivalent to 29.1 mcg epinephrine bitartrate), and the higher strength contains 16 mg (64 mcg epinephrine base per mL which is equivalent to 116.4 mcg epinephrine bitartrate), in 250 mL VIAFLO bag. In 250 ml, each 1 mL of Epinephrine in 0.9% Sodium Chloride Injection solution contains 0.032 mg edetate disodium, 9 mg sodium chloride, 0.05 mg sodium metabisulfite, water for injection, hydrochloric acid (q.s) and/or sodium hydroxide (q.s) to adjust pH range of 3.4 to 4.5. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. VIAFLO bag is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0024-20</NDCCode>
    <PackageDescription>20 BAG in 1 CARTON (0338-0024-20)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-0024-20</NDC11Code>
    <ProductNDC>0338-0024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinephrine</ProprietaryName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250228</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218475</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>EPINEPHRINE BITARTRATE</SubstanceName>
    <StrengthNumber>64</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinephrine in 0.9% Sodium Chloride Injection is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.1).</IndicationAndUsage>
    <Description>Epinephrine in Sodium Chloride injection contains active moiety, Epinephrine, a sympathomimetic catecholamine (adrenergic agent) in the form of Bitartrate salt. The chemical name of Epinephrine Bitartrate, USP, is 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). It is a white or greyish-white or light brownish-grey, odourless, crystalline powder, and slowly darkens on exposure to air and light. It has the following structural formula. The molecular weight of epinephrine bitartrate is 333.3 and molecular formula is C9H13NO3  C4H6O6. Epinephrine in 0.9% Sodium Chloride Injection is a clear, colorless sterile solution for intravenous administration, available in two strengths 4 mg/250 mL (16 mcg/mL) and 16 mg/250 mL (64 mcg/mL). The lower strength contains 4 mg (16 mcg epinephrine base per mL which is equivalent to 29.1 mcg epinephrine bitartrate), and the higher strength contains 16 mg (64 mcg epinephrine base per mL which is equivalent to 116.4 mcg epinephrine bitartrate), in 250 mL VIAFLO bag. In 250 ml, each 1 mL of Epinephrine in 0.9% Sodium Chloride Injection solution contains 0.032 mg edetate disodium, 9 mg sodium chloride, 0.05 mg sodium metabisulfite, water for injection, hydrochloric acid (q.s) and/or sodium hydroxide (q.s) to adjust pH range of 3.4 to 4.5. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. VIAFLO bag is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>0440-7100-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0440-7100-30)</PackageDescription>
    <NDC11Code>00440-7100-30</NDC11Code>
    <ProductNDC>0440-7100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062884</ApplicationNumber>
    <LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in  the conditions listed below. Infections of the ear, nose and throat- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract- due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure- due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp. or E. coli. Infections of the lower respiratory tract- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections)- due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy: Amoxicillin/clarithromycin/lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or l-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). Dual Therapy: Amoxicillin/lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
    <Description>Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin capsules, tablets and powder for oral suspension are intended for oral administration. Amoxicillin Capsules provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Amoxicillin Capsules, USP also contain Magnesium Stearate, NF; Sodium Lauryl Sulfate, NF. The capsule shell contains D&amp;C red No. 33; FD&amp;C blue No. 1; FD&amp;C red No. 40; FD&amp;C yellow No. 6; Gelatin, NF; Sodium Lauryl Sulfate, NF Titanium Dioxide, USP. Each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets provide amoxicillin trihydrate equivalent to 875 mg. In addition each tablet contains the following inactive ingredients: Sodium Starch Glycolate, NF; Pregelatinized Starch, NF; Colloidal Silicon Dioxide, NF; Povidone, USP; Magnesium Stearate, NF; Polyvinyl Alcohol, USP; Titanium Dioxide, USP; Talc, NF; Polyethylene Glycol, NF and Lecithin, NF. Each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension is a dry powder and when reconstituted according to directions, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin per 5 mL. Amoxicillin for Oral Suspension, USP also contains flavors; casing color (FD&amp;C red No. 40 and FD&amp;C yellow No. 6); Microcrystalline Cellulose and Carboxymethylcellulose Sodium, NF; Colloidal Silicon Dioxide, NF; Sodium Citrate, USP; Sodium Propionate, NF; Sucrose NF. Each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium.</Description>
  </NDC>
</NDCList>