RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <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>72606-514-02</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72606-514-02) </PackageDescription>
    <NDC11Code>72606-0514-02</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>72606-022-04</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>72606-515-04</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>0944-3051-02</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0944-3051-02)  / 1 CONTAINER in 1 BLISTER PACK (0944-3051-03)  / 1 KIT in 1 CONTAINER (0944-3051-04)  *  5 mL in 1 VIAL, GLASS (0944-2941-01)  *  2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
    <NDC11Code>00944-3051-02</NDC11Code>
    <ProductNDC>0944-3051</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Advate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125063</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-3052-02</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0944-3052-02)  / 1 CONTAINER in 1 BLISTER PACK (0944-3052-03)  / 1 KIT in 1 CONTAINER (0944-3052-04)  *  5 mL in 1 VIAL, GLASS (0944-2942-02)  *  2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
    <NDC11Code>00944-3052-02</NDC11Code>
    <ProductNDC>0944-3052</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Advate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125063</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-3053-02</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0944-3053-02)  / 1 CONTAINER in 1 BLISTER PACK (0944-3053-04)  / 1 KIT in 1 CONTAINER (0944-3053-03)  *  5 mL in 1 VIAL, GLASS (0944-2943-02)  *  2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
    <NDC11Code>00944-3053-02</NDC11Code>
    <ProductNDC>0944-3053</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Advate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125063</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
  </NDC>
  <NDC>
    <NDCCode>0944-3054-02</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0944-3054-02)  / 1 CONTAINER in 1 BLISTER PACK (0944-3054-03)  / 1 KIT in 1 CONTAINER (0944-3054-04)  *  5 mL in 1 VIAL, GLASS (0944-2944-02)  *  2 mL in 1 VIAL, GLASS (64764-514-02) </PackageDescription>
    <NDC11Code>00944-3054-02</NDC11Code>
    <ProductNDC>0944-3054</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Advate</ProprietaryName>
    <NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20111215</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125063</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: 1 Control and prevention of bleeding episodes., 2 Perioperative management., 3 Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.</IndicationAndUsage>
    <Description>ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE® [Antihemophilic Factor (Recombinant)]. ADVATE has been shown to be comparable to RECOMBINATE with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology. In culture, the CHO cell line expresses the recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human antihemophilic factor (hAHF). Structurally, the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human). ADVATE is formulated as a sterile, nonpyrogenic, white to off-white powder for intravenous injection. ADVATE in a single-dose vial contains nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU). The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione. Von Willebrand factor (VWF) is co-expressed with factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative. When reconstituted with the provided Sterile Water for Injection, USP, the final solution contains the following stabilizers and excipients in targeted amounts:. Each ADVATE housing is labeled with the rAHF activity expressed in international units. Biological potency is determined by an in vitro assay, which employs a factor VIII concentrate standard that is referenced to a WHO international standard for factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.</Description>
  </NDC>
  <NDC>
    <NDCCode>42549-514-04</NDCCode>
    <PackageDescription>140 TABLET in 1 BOTTLE (42549-514-04)</PackageDescription>
    <NDC11Code>42549-0514-04</NDC11Code>
    <ProductNDC>42549-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040400</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains. In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. The 10 mg/650 mg tablet also contains FD &amp; C Blue No. 1 Aluminum Lake 12%. Meets USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>44183-514-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (44183-514-04)</PackageDescription>
    <NDC11Code>44183-0514-04</NDC11Code>
    <ProductNDC>44183-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>V-cof</ProprietaryName>
    <NonProprietaryName>Brompheniramine Maleate, Phenylephrine Hydrochloride, And Carbetapentane Citrate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100204</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Macoven Pharmaceuticals</LabelerName>
    <SubstanceName>BROMPHENIRAMINE MALEATE; CARBETAPENTANE CITRATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6; 25; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-30</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>61787-514-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (61787-514-04)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61787-0514-04</NDC11Code>
    <ProductNDC>61787-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diabetic Tussin Expectorant</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>MEDTECH PRODUCTS INC</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62980-514-04</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62980-514-04) </PackageDescription>
    <NDC11Code>62980-0514-04</NDC11Code>
    <ProductNDC>62980-514</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <ProprietaryNameSuffix>150 Mg</ProprietaryNameSuffix>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190401</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210010</ApplicationNumber>
    <LabelerName>Vivimed Labs Limited</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84522-514-04</NDCCode>
    <PackageDescription>50 g in 1 BOX (84522-514-04) </PackageDescription>
    <NDC11Code>84522-0514-04</NDC11Code>
    <ProductNDC>84522-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Whitening Cream</ProprietaryName>
    <NonProprietaryName>Trstay Whitening Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241214</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-514-04</NDCCode>
    <PackageDescription>50 g in 1 BOX (84756-514-04) </PackageDescription>
    <NDC11Code>84756-0514-04</NDC11Code>
    <ProductNDC>84756-514</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mooyam Retinol Face Cream</ProprietaryName>
    <NonProprietaryName>Mooyam Retinol Face Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72606-506-02</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (72606-506-02)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72606-0506-02</NDC11Code>
    <ProductNDC>72606-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-506-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (72606-506-03) </PackageDescription>
    <NDC11Code>72606-0506-03</NDC11Code>
    <ProductNDC>72606-506</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-507-02</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (72606-507-02)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72606-0507-02</NDC11Code>
    <ProductNDC>72606-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-507-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (72606-507-03) </PackageDescription>
    <NDC11Code>72606-0507-03</NDC11Code>
    <ProductNDC>72606-507</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-508-02</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (72606-508-02)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72606-0508-02</NDC11Code>
    <ProductNDC>72606-508</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>72606-508-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (72606-508-03) </PackageDescription>
    <NDC11Code>72606-0508-03</NDC11Code>
    <ProductNDC>72606-508</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Telmisartan</ProprietaryName>
    <NonProprietaryName>Telmisartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078710</ApplicationNumber>
    <LabelerName>CELLTRION USA, INC.</LabelerName>
    <SubstanceName>TELMISARTAN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
    <Description>Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan, USP is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan Tablets USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Telmisartan Tablets USP are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0042-37</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0597-0042-37)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00597-0042-37</NDC11Code>
    <ProductNDC>0597-0042</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micardis Hct</ProprietaryName>
    <NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021162</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. MICARDIS HCT is not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. MICARDIS HCT may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>MICARDIS HCT tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. MICARDIS HCT tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. MICARDIS HCT tablets are hygroscopic and require protection from moisture.</Description>
  </NDC>
  <NDC>
    <NDCCode>0597-0043-37</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0597-0043-37)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00597-0043-37</NDC11Code>
    <ProductNDC>0597-0043</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micardis Hct</ProprietaryName>
    <NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001201</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021162</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>40; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. MICARDIS HCT is not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. MICARDIS HCT may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
    <Description>MICARDIS HCT tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. MICARDIS HCT tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. MICARDIS HCT tablets are hygroscopic and require protection from moisture.</Description>
  </NDC>
</NDCList>