RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>72606-022-04</NDCCode>
    <PackageDescription>6 KIT in 1 CARTON (72606-022-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-04</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-023-04</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (72606-023-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0023-04</NDC11Code>
    <ProductNDC>72606-023</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Yuflyma</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230929</StartMarketingDate>
    <EndMarketingDate>20280531</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230929</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. YUFLYMA (adalimumab-aaty) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (YUFLYMA AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of YUFLYMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of YUFLYMA contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of YUFLYMA contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of YUFLYMA contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of YUFLYMA contains adalimumab-aaty (10 mg), acetic acid (0.02 mg), glycine (1.88 mg), polysorbate 80 (0.1 mg), sodium acetate (0.06 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-025-04</NDCCode>
    <PackageDescription>6 KIT in 1 CARTON (72606-025-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0025-04</NDC11Code>
    <ProductNDC>72606-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zymfentra</ProprietaryName>
    <NonProprietaryName>Infliximab-dyyb</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240301</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761358</ApplicationNumber>
    <LabelerName>CELLTRION USA Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: 1 moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. (1).</IndicationAndUsage>
    <Description>Infliximab-dyyb, 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 145.9 kDa. Infliximab-dyyb is produced by a recombinant murine myeloma cell line, SP2/0. ZYMFENTRA (inifliximab-dyyb) injection for subcutaneous use is a sterile, preservative-free, clear to opalescent, colorless to pale brown solution. ZYMFENTRA is supplied in a single-dose prefilled syringe with 29 gauge fixed 1/2 inch needle, prefilled syringe with 29 gauge fixed 1/2 inch needle with needle guard, or prefilled pen with 27 gauge fixed 1/2 inch needle. Each mL of solution contains 120 mg infliximab-dyyb, acetic acid (0.19 mg), polysorbate 80 (0.5 mg), sodium acetate (0.56 mg), sorbitol (45 mg) and Water for Injection, USP. The pH is 5.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-030-04</NDCCode>
    <PackageDescription>6 KIT in 1 CARTON (72606-030-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0030-04</NDC11Code>
    <ProductNDC>72606-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Yuflyma</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230523</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>72606-040-04</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (72606-040-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0040-04</NDC11Code>
    <ProductNDC>72606-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-045-04</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (72606-045-04)  / .9 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>72606-0045-04</NDC11Code>
    <ProductNDC>72606-045</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avtozma</ProprietaryName>
    <NonProprietaryName>Tocilizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260201</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761498</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <SubstanceName>TOCILIZUMAB</SubstanceName>
    <StrengthNumber>162</StrengthNumber>
    <StrengthUnit>mg/.9mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).</IndicationAndUsage>
    <Description>Tocilizumab-anoh is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-anoh has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-051-04</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 CARTON (72606-051-04)  / .9 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>72606-0051-04</NDC11Code>
    <ProductNDC>72606-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tocilizumab-anoh</ProprietaryName>
    <NonProprietaryName>Tocilizumab-anoh</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20261001</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761498</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <SubstanceName>TOCILIZUMAB</SubstanceName>
    <StrengthNumber>162</StrengthNumber>
    <StrengthUnit>mg/.9mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tocilizumab-anoh is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) (1.1): 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).</IndicationAndUsage>
    <Description>Tocilizumab-anoh is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-anoh has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-509-04</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72606-509-04) </PackageDescription>
    <NDC11Code>72606-0509-04</NDC11Code>
    <ProductNDC>72606-509</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200923</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075786</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
    <Description>The active ingredient in Famotidine Tablets USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each Famotidine Tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine USP and the following inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, ls-hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. Famotidine USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-510-04</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72606-510-04) </PackageDescription>
    <NDC11Code>72606-0510-04</NDC11Code>
    <ProductNDC>72606-510</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200923</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075786</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
    <Description>The active ingredient in Famotidine Tablets USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each Famotidine Tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine USP and the following inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, ls-hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. Famotidine USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-514-04</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (72606-514-04) </PackageDescription>
    <NDC11Code>72606-0514-04</NDC11Code>
    <ProductNDC>72606-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090073</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
    <Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&amp;C Yellow #6 and FD&amp;C Blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-515-04</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (72606-515-04) </PackageDescription>
    <NDC11Code>72606-0515-04</NDC11Code>
    <ProductNDC>72606-515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090073</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
    <Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&amp;C Yellow #6 and FD&amp;C Blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-022-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (72606-022-01)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-01</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-022-02</NDCCode>
    <PackageDescription>2 KIT in 1 CARTON (72606-022-02)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-02</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-022-03</NDCCode>
    <PackageDescription>4 KIT in 1 CARTON (72606-022-03)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-03</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-022-05</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (72606-022-05)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-05</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-022-06</NDCCode>
    <PackageDescription>2 KIT in 1 CARTON (72606-022-06)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET</PackageDescription>
    <NDC11Code>72606-0022-06</NDC11Code>
    <ProductNDC>72606-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adalimumab</ProprietaryName>
    <NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761219</ApplicationNumber>
    <LabelerName>CELLTRION USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
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    <NDCCode>14445-022-04</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (14445-022-04) </PackageDescription>
    <NDC11Code>14445-0022-04</NDC11Code>
    <ProductNDC>14445-022</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
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    <StartMarketingDate>20210708</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Indoco Remedies Limited</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-03-13</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-JUL-21</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>16714-022-04</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16714-022-04)</PackageDescription>
    <NDC11Code>16714-0022-04</NDC11Code>
    <ProductNDC>16714-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078213</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-05</LastUpdate>
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  <NDC>
    <NDCCode>21749-022-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (21749-022-04) </PackageDescription>
    <NDC11Code>21749-0022-04</NDC11Code>
    <ProductNDC>21749-022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purell Advanced Hand Sanitizer Biobased Content</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>GOJO Industries, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
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    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use .</IndicationAndUsage>
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  <NDC>
    <NDCCode>25225-022-04</NDCCode>
    <PackageDescription>237 g in 1 BOTTLE, PLASTIC (25225-022-04)</PackageDescription>
    <NDC11Code>25225-0022-04</NDC11Code>
    <ProductNDC>25225-022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coconut Vanilla Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Unique Holding Group Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>32228-022-04</NDCCode>
    <PackageDescription>4 BOTTLE in 1 BOX (32228-022-04)  / 1.8 kg in 1 BOTTLE</PackageDescription>
    <NDC11Code>32228-0022-04</NDC11Code>
    <ProductNDC>32228-022</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Infliximab-dyyb</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <StartMarketingDate>20240301</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CELLTRION, Inc.</LabelerName>
    <SubstanceName>INFLIXIMAB-DYYB</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>kg/9kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAR-24</StartMarketingDatePackage>
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    <NDCCode>37000-022-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (37000-022-04)  &gt; 124 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0022-04</NDC11Code>
    <ProductNDC>37000-022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Complete Multi-benefit</ProprietaryName>
    <ProprietaryNameSuffix>Whitening Plus Scope</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20110701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.43</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42961-022-04</NDCCode>
    <PackageDescription>10 PACKET in 1 BAG (42961-022-04)  / .13 mg in 1 PACKET (42961-022-01) </PackageDescription>
    <NDC11Code>42961-0022-04</NDC11Code>
    <ProductNDC>42961-022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Xpect Antiseptic Wipes</ProprietaryName>
    <NonProprietaryName>Antiseptic Cleanser</NonProprietaryName>
    <DosageFormName>SPONGE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Cintas Corporation</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>mg/.13mg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to reduce bacteria in minor cuts, scrapes and burns.</IndicationAndUsage>
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    <NDCCode>43328-022-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (43328-022-04)  / 1 FILM in 1 POUCH</PackageDescription>
    <NDC11Code>43328-0022-04</NDC11Code>
    <ProductNDC>43328-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210858</ApplicationNumber>
    <LabelerName>Altergon Italia srl</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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