RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>57894-651-22</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-651-22)  / 2 mL in 1 SYRINGE (57894-651-11) </PackageDescription>
    <NDC11Code>57894-0651-22</NDC11Code>
    <ProductNDC>57894-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tremfya</ProprietaryName>
    <NonProprietaryName>Guselkumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761061</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GUSELKUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TREMFYA is an interleukin-23 antagonist indicated for the treatment of: 1 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. (1.1), 2 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. (1.2), 3 adults with moderately to severely active ulcerative colitis. (1.3), 4 adults with moderately to severely active Crohn's disease. (1.4).</IndicationAndUsage>
    <Description>Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa. TREMFYA® (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution. TREMFYA for Subcutaneous Injection. Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 1 mL or 2 mL prefilled pen (TREMFYA PEN), or in a 1 mL One-Press patient-controlled injector for subcutaneous use. : 1 Each TREMFYA 1 mL prefilled syringe, prefilled pen (TREMFYA PEN), or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8., 2 Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-522-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (57894-522-01)  / 22 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>57894-0522-01</NDC11Code>
    <ProductNDC>57894-522</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rybrevant Faspro</ProprietaryName>
    <NonProprietaryName>Amivantamab And Hyaluronidase-lpuj (human Recombinant)</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260213</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761433</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
    <StrengthNumber>3520; 44000</StrengthNumber>
    <StrengthUnit>mg/22mL; mg/22mL</StrengthUnit>
    <Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>RYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: 1 in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. (1, 2.2), 2 in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. (1, 2.2), 3 in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. (1, 2.2), 4 as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (1, 2.2).</IndicationAndUsage>
    <Description>RYBREVANT FASPRO is a fixed-combination drug product containing amivantamab and hyaluronidase (human recombinant). : 1 Amivantamab is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa., 2 Hyaluronidase (human recombinant) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by CHO cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (human recombinant) has a molecular weight of approximately 61 kDa.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-651-02</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-651-02)  / 2 mL in 1 SYRINGE (57894-651-01) </PackageDescription>
    <NDC11Code>57894-0651-02</NDC11Code>
    <ProductNDC>57894-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tremfya</ProprietaryName>
    <NonProprietaryName>Guselkumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761061</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GUSELKUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TREMFYA is an interleukin-23 antagonist indicated for the treatment of: 1 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. (1.1), 2 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. (1.2), 3 adults with moderately to severely active ulcerative colitis. (1.3), 4 adults with moderately to severely active Crohn's disease. (1.4).</IndicationAndUsage>
    <Description>Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa. TREMFYA® (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution. TREMFYA for Subcutaneous Injection. Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 1 mL or 2 mL prefilled pen (TREMFYA PEN), or in a 1 mL One-Press patient-controlled injector for subcutaneous use. : 1 Each TREMFYA 1 mL prefilled syringe, prefilled pen (TREMFYA PEN), or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8., 2 Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-651-04</NDCCode>
    <PackageDescription>2 CARTON in 1 CARTON (57894-651-04)  / 1 SYRINGE in 1 CARTON (57894-651-02)  / 2 mL in 1 SYRINGE (57894-651-01) </PackageDescription>
    <NDC11Code>57894-0651-04</NDC11Code>
    <ProductNDC>57894-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tremfya</ProprietaryName>
    <NonProprietaryName>Guselkumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761061</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GUSELKUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TREMFYA is an interleukin-23 antagonist indicated for the treatment of: 1 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. (1.1), 2 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. (1.2), 3 adults with moderately to severely active ulcerative colitis. (1.3), 4 adults with moderately to severely active Crohn's disease. (1.4).</IndicationAndUsage>
    <Description>Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa. TREMFYA® (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution. TREMFYA for Subcutaneous Injection. Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 1 mL or 2 mL prefilled pen (TREMFYA PEN), or in a 1 mL One-Press patient-controlled injector for subcutaneous use. : 1 Each TREMFYA 1 mL prefilled syringe, prefilled pen (TREMFYA PEN), or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8., 2 Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-651-92</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-651-92)  / 2 mL in 1 SYRINGE (57894-651-99) </PackageDescription>
    <NDC11Code>57894-0651-92</NDC11Code>
    <ProductNDC>57894-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tremfya</ProprietaryName>
    <NonProprietaryName>Guselkumab</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240911</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761061</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GUSELKUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TREMFYA is an interleukin-23 antagonist indicated for the treatment of: 1 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. (1.1), 2 adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. (1.2), 3 adults with moderately to severely active ulcerative colitis. (1.3), 4 adults with moderately to severely active Crohn's disease. (1.4).</IndicationAndUsage>
    <Description>Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa. TREMFYA® (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution. TREMFYA for Subcutaneous Injection. Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 1 mL or 2 mL prefilled pen (TREMFYA PEN), or in a 1 mL One-Press patient-controlled injector for subcutaneous use. : 1 Each TREMFYA 1 mL prefilled syringe, prefilled pen (TREMFYA PEN), or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8., 2 Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-449-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01)  / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>57894-0449-01</NDC11Code>
    <ProductNDC>57894-449</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tecvayli</ProprietaryName>
    <NonProprietaryName>Teclistamab-cqyv</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20221025</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761291</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>TECLISTAMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: 1 in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent., 2 as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.</IndicationAndUsage>
    <Description>Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody. Teclistamab-cqyv is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. Teclistamab-cqyv consists of an anti-BCMA heavy chain and light chain and an anti-CD3 heavy chain and light chain with two interchain disulfide bonds connecting the two arms. The molecular weight of teclistamab-cqyv is approximately 146 kDa. TECVAYLI® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied in a single-dose vial for subcutaneous administration. Each TECVAYLI 3 mL single-dose vial contains 30 mg of teclistamab-cqyv, edetate disodium (0.054 mg), glacial acetic acid (0.72 mg), polysorbate 20 (1.2 mg), sodium acetate (2.7 mg), sucrose (240 mg), and Water for Injection, USP. Each TECVAYLI 1.7 mL single-dose vial contains 153 mg of teclistamab-cqyv, edetate disodium (0.031 mg), glacial acetic acid (0.41 mg), polysorbate 20 (0.68 mg), sodium acetate (1.5 mg), sucrose (140 mg), and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-450-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (57894-450-01)  / 1.7 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>57894-0450-01</NDC11Code>
    <ProductNDC>57894-450</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tecvayli</ProprietaryName>
    <NonProprietaryName>Teclistamab-cqyv</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20221025</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761291</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>TECLISTAMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: 1 in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent., 2 as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.</IndicationAndUsage>
    <Description>Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody. Teclistamab-cqyv is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. Teclistamab-cqyv consists of an anti-BCMA heavy chain and light chain and an anti-CD3 heavy chain and light chain with two interchain disulfide bonds connecting the two arms. The molecular weight of teclistamab-cqyv is approximately 146 kDa. TECVAYLI® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied in a single-dose vial for subcutaneous administration. Each TECVAYLI 3 mL single-dose vial contains 30 mg of teclistamab-cqyv, edetate disodium (0.054 mg), glacial acetic acid (0.72 mg), polysorbate 20 (1.2 mg), sodium acetate (2.7 mg), sucrose (240 mg), and Water for Injection, USP. Each TECVAYLI 1.7 mL single-dose vial contains 153 mg of teclistamab-cqyv, edetate disodium (0.031 mg), glacial acetic acid (0.41 mg), polysorbate 20 (0.68 mg), sodium acetate (1.5 mg), sucrose (140 mg), and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>11673-153-11</NDCCode>
    <PackageDescription>651 mL in 1 BOTTLE, PLASTIC (11673-153-11) </PackageDescription>
    <NDC11Code>11673-0153-11</NDC11Code>
    <ProductNDC>11673-153</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Everyday Clean Dandruff</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19950215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11673-643-11</NDCCode>
    <PackageDescription>651 mL in 1 BOTTLE, PLASTIC (11673-643-11) </PackageDescription>
    <NDC11Code>11673-0643-11</NDC11Code>
    <ProductNDC>11673-643</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>2 In 1 Dandruff</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201109</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42549-651-12</NDCCode>
    <PackageDescription>120 CAPSULE in 1 BOTTLE, PLASTIC (42549-651-12)</PackageDescription>
    <NDC11Code>42549-0651-12</NDC11Code>
    <ProductNDC>42549-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070920</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule shell for all strengths contains FD&amp;C Yellow No. 6, gelatin and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>42549-651-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (42549-651-30)</PackageDescription>
    <NDC11Code>42549-0651-30</NDC11Code>
    <ProductNDC>42549-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070920</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule shell for all strengths contains FD&amp;C Yellow No. 6, gelatin and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>42549-651-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (42549-651-60)</PackageDescription>
    <NDC11Code>42549-0651-60</NDC11Code>
    <ProductNDC>42549-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070920</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule shell for all strengths contains FD&amp;C Yellow No. 6, gelatin and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>42549-651-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (42549-651-90)</PackageDescription>
    <NDC11Code>42549-0651-90</NDC11Code>
    <ProductNDC>42549-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070920</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule shell for all strengths contains FD&amp;C Yellow No. 6, gelatin and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>51079-651-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (51079-651-20)  / 1 CAPSULE in 1 BLISTER PACK (51079-651-01) </PackageDescription>
    <NDC11Code>51079-0651-20</NDC11Code>
    <ProductNDC>51079-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070791</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
    <Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO  HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e]oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&amp;C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&amp;C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&amp;C Green No. 3. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-651-52</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-651-52)</PackageDescription>
    <NDC11Code>51655-0651-52</NDC11Code>
    <ProductNDC>51655-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077492</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69842-651-01</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (69842-651-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69842-0651-01</NDC11Code>
    <ProductNDC>69842-651</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Congestion And Headache</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CVS PHARMACY</LabelerName>
    <SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 200; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20201014</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold and flu symptoms: nasal congestionheadacheminor aches and painssinus congestion and pressure. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily reduces fever. temporarily promotes nasal and/or sinus drainage.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57894-030-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 BOX (57894-030-01)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>57894-0030-01</NDC11Code>
    <ProductNDC>57894-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Remicade</ProprietaryName>
    <NonProprietaryName>Infliximab</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19980824</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103772</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>INFLIXIMAB</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REMICADE is a tumor necrosis factor (TNF) blocker indicated for: 1 Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1) , 2 Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2) , 3 Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.3) , 4 Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.4) , 5 Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5) , 6 Ankylosing Spondylitis: reducing signs and symptoms in adult patients with active disease. ( 1.6) , 7 Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients. ( 1.7) , 8 Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. ( 1.8) .</IndicationAndUsage>
    <Description>Infliximab, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab is produced by a recombinant murine myeloma cell line, SP2/0. REMICADE ®(infliximab) for injection is supplied as a sterile, preservative-free, white, lyophilized powder for intravenous infusion after reconstitution and dilution. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the final concentration is 10 mg/mL and the resulting pH is approximately 7.2. Each single-dose vial contains 100 mg infliximab, dibasic sodium phosphate, dihydrate (6.1 mg), monobasic sodium phosphate, monohydrate (2.2 mg), polysorbate 80 (0.5 mg), and sucrose (500 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-050-60</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (57894-050-60)  / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>57894-0050-60</NDC11Code>
    <ProductNDC>57894-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Akeega</ProprietaryName>
    <NonProprietaryName>Niraparib Tosylate Monohydrate And Abiraterone Acetate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230811</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216793</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>NIRAPARIB TOSYLATE MONOHYDRATE; ABIRATERONE ACETATE</SubstanceName>
    <StrengthNumber>50; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated ( BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated ( BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1)] .</IndicationAndUsage>
    <Description>AKEEGA ® (niraparib and abiraterone acetate) tablets contain niraparib tosylate (as the monohydrate) and abiraterone acetate.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-054-16</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 BOX (57894-054-16)  / 26 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>57894-0054-16</NDC11Code>
    <ProductNDC>57894-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160923</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761044</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/26mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170501</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-054-27</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 BOX (57894-054-27)  / 26 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>57894-0054-27</NDC11Code>
    <ProductNDC>57894-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160923</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761044</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/26mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-060-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02)  / .5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>57894-0060-02</NDC11Code>
    <ProductNDC>57894-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-060-03</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-060-03)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0060-03</NDC11Code>
    <ProductNDC>57894-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-060-04</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-060-04)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0060-04</NDC11Code>
    <ProductNDC>57894-060</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090925</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-061-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (57894-061-02)  &gt; 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>57894-0061-02</NDC11Code>
    <ProductNDC>57894-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC],Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57894-061-03</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-061-03)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0061-03</NDC11Code>
    <ProductNDC>57894-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-061-04</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-061-04)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0061-04</NDC11Code>
    <ProductNDC>57894-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Stelara</ProprietaryName>
    <NonProprietaryName>Ustekinumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090925</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125261</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090925</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. (1.3), 4 Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7–6.3. STELARA for Subcutaneous Use. Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). STELARA for Intravenous Infusion. Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-070-01</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (57894-070-01)  / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>57894-0070-01</NDC11Code>
    <ProductNDC>57894-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simponi</ProprietaryName>
    <NonProprietaryName>Golimumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090425</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125289</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GOLIMUMAB</SubstanceName>
    <StrengthNumber>50</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>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1) , 2 adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2) , 3 adult patients with active ankylosing spondylitis (AS) ( 1.3) , 4 adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) (1.4).</IndicationAndUsage>
    <Description>Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. Golimumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. SIMPONI ®(golimumab) Injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution of the golimumab antibody supplied in a single-dose prefilled syringe (with a passive needle safety guard) or a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe and autoinjector contains 50 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.44 mg), polysorbate 80 (0.08 mg), sorbitol (20.5 mg) and Water for Injection. Each 1 mL prefilled syringe and autoinjector contains 100 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.87 mg), polysorbate 80 (0.15 mg), sorbitol (41.0 mg) and Water for Injection. The pH is approximately 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-070-02</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-070-02)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0070-02</NDC11Code>
    <ProductNDC>57894-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simponi</ProprietaryName>
    <NonProprietaryName>Golimumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090425</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125289</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GOLIMUMAB</SubstanceName>
    <StrengthNumber>50</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>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1) , 2 adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2) , 3 adult patients with active ankylosing spondylitis (AS) ( 1.3) , 4 adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) (1.4).</IndicationAndUsage>
    <Description>Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. Golimumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. SIMPONI ®(golimumab) Injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution of the golimumab antibody supplied in a single-dose prefilled syringe (with a passive needle safety guard) or a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe and autoinjector contains 50 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.44 mg), polysorbate 80 (0.08 mg), sorbitol (20.5 mg) and Water for Injection. Each 1 mL prefilled syringe and autoinjector contains 100 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.87 mg), polysorbate 80 (0.15 mg), sorbitol (41.0 mg) and Water for Injection. The pH is approximately 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-070-89</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (57894-070-89)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>57894-0070-89</NDC11Code>
    <ProductNDC>57894-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simponi</ProprietaryName>
    <NonProprietaryName>Golimumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090425</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125289</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GOLIMUMAB</SubstanceName>
    <StrengthNumber>50</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>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090425</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1) , 2 adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2) , 3 adult patients with active ankylosing spondylitis (AS) ( 1.3) , 4 adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) (1.4).</IndicationAndUsage>
    <Description>Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. Golimumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. SIMPONI ®(golimumab) Injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution of the golimumab antibody supplied in a single-dose prefilled syringe (with a passive needle safety guard) or a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe and autoinjector contains 50 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.44 mg), polysorbate 80 (0.08 mg), sorbitol (20.5 mg) and Water for Injection. Each 1 mL prefilled syringe and autoinjector contains 100 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.87 mg), polysorbate 80 (0.15 mg), sorbitol (41.0 mg) and Water for Injection. The pH is approximately 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>57894-070-90</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (57894-070-90)  / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>57894-0070-90</NDC11Code>
    <ProductNDC>57894-070</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simponi</ProprietaryName>
    <NonProprietaryName>Golimumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20090425</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125289</ApplicationNumber>
    <LabelerName>Janssen Biotech, Inc.</LabelerName>
    <SubstanceName>GOLIMUMAB</SubstanceName>
    <StrengthNumber>50</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>2026-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090425</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1) , 2 adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2) , 3 adult patients with active ankylosing spondylitis (AS) ( 1.3) , 4 adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) (1.4).</IndicationAndUsage>
    <Description>Golimumab is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. Golimumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. SIMPONI ®(golimumab) Injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution of the golimumab antibody supplied in a single-dose prefilled syringe (with a passive needle safety guard) or a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe and autoinjector contains 50 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.44 mg), polysorbate 80 (0.08 mg), sorbitol (20.5 mg) and Water for Injection. Each 1 mL prefilled syringe and autoinjector contains 100 mg golimumab, L-histidine and L-histidine monohydrochloride monohydrate (0.87 mg), polysorbate 80 (0.15 mg), sorbitol (41.0 mg) and Water for Injection. The pH is approximately 5.5.</Description>
  </NDC>
</NDCList>