{
"NDC": [
{
"NDCCode": "83457-107-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (83457-107-01) / .8 mL in 1 SYRINGE",
"NDC11Code": "83457-0107-01",
"ProductNDC": "83457-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-100-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (83457-100-01) / .4 mL in 1 SYRINGE",
"NDC11Code": "83457-0100-01",
"ProductNDC": "83457-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-101-01",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (83457-101-01) / .4 mL in 1 SYRINGE, GLASS",
"NDC11Code": "83457-0101-01",
"ProductNDC": "83457-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-102-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (83457-102-01) / .8 mL in 1 SYRINGE",
"NDC11Code": "83457-0102-01",
"ProductNDC": "83457-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-103-01",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (83457-103-01) / .8 mL in 1 SYRINGE, GLASS",
"NDC11Code": "83457-0103-01",
"ProductNDC": "83457-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-108-01",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (83457-108-01) / .2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "83457-0108-01",
"ProductNDC": "83457-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-112-01",
"PackageDescription": "1 KIT in 1 CARTON (83457-112-01) * 2 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE * 1 SYRINGE in 1 CARTON / .8 mL in 1 SYRINGE",
"NDC11Code": "83457-0112-01",
"ProductNDC": "83457-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "KIT",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-113-01",
"PackageDescription": "3 SYRINGE in 1 CARTON (83457-113-01) / .8 mL in 1 SYRINGE",
"NDC11Code": "83457-0113-01",
"ProductNDC": "83457-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyrimoz",
"NonProprietaryName": "Adalimumab-adaz",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761071",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"Description": "Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH."
},
{
"NDCCode": "83457-124-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-124-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-123-01) / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0124-02",
"ProductNDC": "83457-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older. (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) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-186-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (83457-186-01) / .4 mL in 1 SYRINGE (83457-186-99) ",
"NDC11Code": "83457-0186-01",
"ProductNDC": "83457-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-bwwd",
"NonProprietaryName": "Adalimumab-bwwd",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-bwwd 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 adult patients (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9).",
"Description": "Adalimumab-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd 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-bwwd 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-bwwd injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (Adalimumab-bwwd autoinjector) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-bwwd is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-187-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (83457-187-01) / .4 mL in 1 SYRINGE (83457-187-99) ",
"NDC11Code": "83457-0187-01",
"ProductNDC": "83457-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-bwwd",
"NonProprietaryName": "Adalimumab-bwwd",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "Cordavis Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-bwwd 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 adult patients (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9).",
"Description": "Adalimumab-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd 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-bwwd 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-bwwd injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (Adalimumab-bwwd autoinjector) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-bwwd is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-243-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-243-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-242-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0243-02",
"ProductNDC": "83457-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older. (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) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-554-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-554-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-553-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0554-02",
"ProductNDC": "83457-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older. (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) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-616-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-616-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-615-01) / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0616-02",
"ProductNDC": "83457-616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older. (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) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "83457-651-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (83457-651-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "83457-0651-01",
"ProductNDC": "83457-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyzchiva",
"NonProprietaryName": "Ustekinumab-ttwe",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761373",
"LabelerName": "Cordavis Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-ttwe, a human IgG1Îş monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg)."
},
{
"NDCCode": "83457-652-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (83457-652-01) / 1 mL in 1 SYRINGE",
"NDC11Code": "83457-0652-01",
"ProductNDC": "83457-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyzchiva",
"NonProprietaryName": "Ustekinumab-ttwe",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761373",
"LabelerName": "Cordavis Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-ttwe, a human IgG1Îş monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg)."
},
{
"NDCCode": "83457-817-02",
"PackageDescription": "2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) ",
"NDC11Code": "83457-0817-02",
"ProductNDC": "83457-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Humira",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "KIT",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125057",
"LabelerName": "Cordavis Limited",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "HUMIRA 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 adults and pediatric patients 5 years of age and older. (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) .",
"Description": "Adalimumab is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "0573-2890-01",
"PackageDescription": "107.7 g in 1 CANISTER (0573-2890-01) ",
"NDC11Code": "00573-2890-01",
"ProductNDC": "0573-2890",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Preparation H Rapid Relief",
"NonProprietaryName": "Lidocaine, Phenylephrine Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Helps relieve the local discomfort and itching associated with hemorrhoids, 2 For the temporary relief of pain, soreness or burning, 3 Temporarily reduces the swelling associated with irritation in hemorrhoids, 4 Temporarily shrinks hemorrhoidal tissue."
},
{
"NDCCode": "0924-0931-01",
"PackageDescription": "107 g in 1 BOTTLE, SPRAY (0924-0931-01) ",
"NDC11Code": "00924-0931-01",
"ProductNDC": "0924-0931",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic First Aid",
"NonProprietaryName": "Benzalkonium Chloride And Benzocaine",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Acme United Corp",
"SubstanceName": "BENZALKONIUM CHLORIDE; BENZOCAINE",
"StrengthNumber": "1; 50",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141006",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns."
},
{
"NDCCode": "10237-107-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-107-01) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "10237-0107-01",
"ProductNDC": "10237-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland Power Mist Hand Sanitizer Pure Lavender",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
},
{
"NDCCode": "10424-107-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10424-107-01) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "10424-0107-01",
"ProductNDC": "10424-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Syimmune",
"NonProprietaryName": "Penicillium Chrysogenum Var. Chrysogenum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140110",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Syntrion GmbH",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10702-107-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10702-107-01) ",
"NDC11Code": "10702-0107-01",
"ProductNDC": "10702-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206931",
"LabelerName": "KVK-TECH, INC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151204",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride tablets contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride tablets is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R, R’)- (+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note: * = asymmetric carbon centers. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients:Dexmethylphenidate hydrochloride tablets also contains the following inert ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Additionally, 5 mg tablets contain D&C Yellow #10 aluminum lake; 2.5 mg tablets contains FD&C Blue #1 aluminum lake."
},
{
"NDCCode": "10812-107-01",
"PackageDescription": "30 CLOTH in 1 CELLO PACK (10812-107-01)",
"NDC11Code": "10812-0107-01",
"ProductNDC": "10812-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Oil Free Acne Wash",
"ProprietaryNameSuffix": "Cleansing",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120329",
"EndMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "11090-107-01",
"PackageDescription": "1 TUBE in 1 CARTON (11090-107-01) > 4 mL in 1 TUBE",
"NDC11Code": "11090-0107-01",
"ProductNDC": "11090-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Itc Cc Full Coverage Cream Medium",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180314",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beauty Manufacturing Solutions Corp.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "90; 63",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180314",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "11489-107-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-107-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0107-01",
"ProductNDC": "11489-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Day Cream Spf 15",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "1.5; 2; 1",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.",
"Description": "No7 Protect and Perfect The Perfect Trio. This trio of No7 Protect and Perfect Intense skincare products is the perfect anti-ageing daily skincare regime. This gift contains. No7 Protect and Perfect Intense ADVANCED Serum 15ml e 0.5 US Fl.Oz. No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 50ml e 1.69 Us Fl.Oz. No7 Protect and Perfect Intense ADVANCED Eye Cream 5ml e 0.16 US Fl.Oz. No7 Protect and Perfect Intense ADVANCED Serum 15ml e 0.5 US Fl.Oz. A serum clinically proven to deliver anti-wrinkle results that get even better over time. Supercharge your skincare regime with this clinically proven serum. No7's highly acclaimed Protect and Perfect Intense technology has been re-engineered to delver even better anti-ageing results. Independently tested and proven to work. With our patented antioxidant complex it helps protect the skin from future signs of ageing, keeping it looking younger for longer. After two weeks skin looks younger, by four weeks deep lines and wrinkles are reduced in appearance and results keep getting better with continued use. For Best Results : Use morning and evening, smooth into your face and neck after cleansing, then moisturise. No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15. 50ml e 1.69 US Fl.Oz. Smooth the appearance of deep lines and wrinkles and help delay new ones with this protecting and renewing daytime formula.It's the perfect partner to our Protect and Perfect Intense ADVANCED Serum. Formulated to be used together to deliver even better results than serum alone. With the protective power of SPF 15 giving your skin protection from the sun and environmental stress. For Best Results: After cleansing, simply smooth into your face and neck with your fingertips, avoiding your eyes. No7 Protect and Perfect Intense ADVANCED Eye Cream 5ml e 0.16 US Fl.Oz. Smooth the appearance of deep lines and wrinkles and help delay new ones with No7's ADVANCED protecting and renewing eye cream. Supercharge by Matrixyl 3000 Plus TM, our unique and most concentrated peptide technology to target deep lines and wrinkles. Especially designed for the delicate area around your eyes, it targets troublesome wrinkles whilst visibly improving dark shadows and puffiness. Contains No7's best antioxidant protection, Double Defence technology. For Best Results: Use morning and evening, dot around eyes and gently blend around contours."
},
{
"NDCCode": "11704-107-01",
"PackageDescription": ".3 mL in 1 SYRINGE, GLASS (11704-107-01) ",
"NDC11Code": "11704-0107-01",
"ProductNDC": "11704-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropen Auto-injector",
"NonProprietaryName": "Atropine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20040917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017106",
"LabelerName": "Meridian Medical Technologies LLC",
"SubstanceName": "ATROPINE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040917",
"SamplePackage": "N",
"IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
"Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
},
{
"NDCCode": "12027-107-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (12027-107-02) > 15 g in 1 CONTAINER (12027-107-01) ",
"NDC11Code": "12027-0107-02",
"ProductNDC": "12027-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Megacushion Foundation",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180105",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Markwins Beauty Products, Inc.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.96; 6.73; 7; 2.5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180111",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "13107-107-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-107-01) ",
"NDC11Code": "13107-0107-01",
"ProductNDC": "13107-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205814",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160517",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of hydromorphone hydrochloride is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. Tablets (for oral administration) contain: 2 mg hydromorphone hydrochloride, USP (light orange to orange colored, mottled, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow #10 aluminum lake, and D&C Red #30 aluminum lake/Helendon Pink aluminum lake.4 mg hydromorphone hydrochloride, USP (light yellow to yellow colored, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10 aluminum lake.8 mg hydromorphone hydrochloride, USP (white to off-white, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "13746-107-01",
"PackageDescription": "25 kg in 1 CONTAINER (13746-107-01) ",
"NDC11Code": "13746-0107-01",
"ProductNDC": "13746-107",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Chlorcyclizine Hydrochloride Bp",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110504",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Srikem Laboratories Pvt. Ltd.",
"SubstanceName": "CHLORCYCLIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-11-03",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "04-MAY-11"
},
{
"NDCCode": "13925-107-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (13925-107-01) ",
"NDC11Code": "13925-0107-01",
"ProductNDC": "13925-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methenamine Mandelate",
"NonProprietaryName": "Methenamine Mandelate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Seton Pharmaceuticals",
"SubstanceName": "METHENAMINE MANDELATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. Therapeutic Use Rationale: Methenamine mandelate helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Methenamine mandelate should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate.",
"Description": "Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets. Methenamine mandelate tablets contain 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and tItanium dioxide."
}
]
}
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<NDCList>
<NDC>
<NDCCode>83457-107-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (83457-107-01) / .8 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83457-0107-01</NDC11Code>
<ProductNDC>83457-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyrimoz</ProprietaryName>
<NonProprietaryName>Adalimumab-adaz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761071</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83457-100-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (83457-100-01) / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83457-0100-01</NDC11Code>
<ProductNDC>83457-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyrimoz</ProprietaryName>
<NonProprietaryName>Adalimumab-adaz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230921</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761071</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
</NDC>
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<NDCCode>83457-101-01</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (83457-101-01) / .4 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>83457-0101-01</NDC11Code>
<ProductNDC>83457-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyrimoz</ProprietaryName>
<NonProprietaryName>Adalimumab-adaz</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230921</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761071</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<Description>Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe PassiveTM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.</Description>
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<PackageDescription>2 KIT in 1 CARTON (83457-124-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-123-01) / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) </PackageDescription>
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<ProprietaryName>Humira</ProprietaryName>
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<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older. (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 is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
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<PackageDescription>2 SYRINGE in 1 CARTON (83457-186-01) / .4 mL in 1 SYRINGE (83457-186-99) </PackageDescription>
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<IndicationAndUsage>Adalimumab-bwwd 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 adult patients (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9).</IndicationAndUsage>
<Description>Adalimumab-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd 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-bwwd 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-bwwd injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (Adalimumab-bwwd autoinjector) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-bwwd is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>Adalimumab-bwwd 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 adult patients (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9).</IndicationAndUsage>
<Description>Adalimumab-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd 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-bwwd 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-bwwd injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (Adalimumab-bwwd autoinjector) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-bwwd is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-bwwd contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older. (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 is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
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<PackageDescription>2 KIT in 1 CARTON (83457-554-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-553-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) </PackageDescription>
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<LabelerName>Cordavis Limited</LabelerName>
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<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older. (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 is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older. (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 is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
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<NDC>
<NDCCode>83457-651-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83457-651-01) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83457-0651-01</NDC11Code>
<ProductNDC>83457-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyzchiva</ProprietaryName>
<NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761373</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-ttwe, a human IgG1Îş monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
</NDC>
<NDC>
<NDCCode>83457-652-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83457-652-01) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83457-0652-01</NDC11Code>
<ProductNDC>83457-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyzchiva</ProprietaryName>
<NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761373</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-ttwe, a human IgG1Îş monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
</NDC>
<NDC>
<NDCCode>83457-817-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01) </PackageDescription>
<NDC11Code>83457-0817-02</NDC11Code>
<ProductNDC>83457-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Humira</ProprietaryName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125057</ApplicationNumber>
<LabelerName>Cordavis Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMIRA 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 adults and pediatric patients 5 years of age and older. (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 is a tumor necrosis factor blocker. Adalimumab 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 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. HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 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 HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0573-2890-01</NDCCode>
<PackageDescription>107.7 g in 1 CANISTER (0573-2890-01) </PackageDescription>
<NDC11Code>00573-2890-01</NDC11Code>
<ProductNDC>0573-2890</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Preparation H Rapid Relief</ProprietaryName>
<NonProprietaryName>Lidocaine, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Helps relieve the local discomfort and itching associated with hemorrhoids, 2 For the temporary relief of pain, soreness or burning, 3 Temporarily reduces the swelling associated with irritation in hemorrhoids, 4 Temporarily shrinks hemorrhoidal tissue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-0931-01</NDCCode>
<PackageDescription>107 g in 1 BOTTLE, SPRAY (0924-0931-01) </PackageDescription>
<NDC11Code>00924-0931-01</NDC11Code>
<ProductNDC>0924-0931</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic First Aid</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride And Benzocaine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Acme United Corp</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; BENZOCAINE</SubstanceName>
<StrengthNumber>1; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-107-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-107-01) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>10237-0107-01</NDC11Code>
<ProductNDC>10237-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland Power Mist Hand Sanitizer Pure Lavender</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10424-107-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10424-107-01) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>10424-0107-01</NDC11Code>
<ProductNDC>10424-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Syimmune</ProprietaryName>
<NonProprietaryName>Penicillium Chrysogenum Var. Chrysogenum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140110</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Syntrion GmbH</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10702-107-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10702-107-01) </PackageDescription>
<NDC11Code>10702-0107-01</NDC11Code>
<ProductNDC>10702-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206931</ApplicationNumber>
<LabelerName>KVK-TECH, INC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride tablets contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride tablets is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R, R’)- (+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note: * = asymmetric carbon centers. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients:Dexmethylphenidate hydrochloride tablets also contains the following inert ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Additionally, 5 mg tablets contain D&C Yellow #10 aluminum lake; 2.5 mg tablets contains FD&C Blue #1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>10812-107-01</NDCCode>
<PackageDescription>30 CLOTH in 1 CELLO PACK (10812-107-01)</PackageDescription>
<NDC11Code>10812-0107-01</NDC11Code>
<ProductNDC>10812-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Oil Free Acne Wash</ProprietaryName>
<ProprietaryNameSuffix>Cleansing</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120329</StartMarketingDate>
<EndMarketingDate>20151101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>11090-107-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11090-107-01) > 4 mL in 1 TUBE</PackageDescription>
<NDC11Code>11090-0107-01</NDC11Code>
<ProductNDC>11090-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Itc Cc Full Coverage Cream Medium</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beauty Manufacturing Solutions Corp.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>90; 63</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11489-107-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-107-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0107-01</NDC11Code>
<ProductNDC>11489-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Day Cream Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>1.5; 2; 1</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.</IndicationAndUsage>
<Description>No7 Protect and Perfect The Perfect Trio. This trio of No7 Protect and Perfect Intense skincare products is the perfect anti-ageing daily skincare regime. This gift contains. No7 Protect and Perfect Intense ADVANCED Serum 15ml e 0.5 US Fl.Oz. No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 50ml e 1.69 Us Fl.Oz. No7 Protect and Perfect Intense ADVANCED Eye Cream 5ml e 0.16 US Fl.Oz. No7 Protect and Perfect Intense ADVANCED Serum 15ml e 0.5 US Fl.Oz. A serum clinically proven to deliver anti-wrinkle results that get even better over time. Supercharge your skincare regime with this clinically proven serum. No7's highly acclaimed Protect and Perfect Intense technology has been re-engineered to delver even better anti-ageing results. Independently tested and proven to work. With our patented antioxidant complex it helps protect the skin from future signs of ageing, keeping it looking younger for longer. After two weeks skin looks younger, by four weeks deep lines and wrinkles are reduced in appearance and results keep getting better with continued use. For Best Results : Use morning and evening, smooth into your face and neck after cleansing, then moisturise. No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15. 50ml e 1.69 US Fl.Oz. Smooth the appearance of deep lines and wrinkles and help delay new ones with this protecting and renewing daytime formula.It's the perfect partner to our Protect and Perfect Intense ADVANCED Serum. Formulated to be used together to deliver even better results than serum alone. With the protective power of SPF 15 giving your skin protection from the sun and environmental stress. For Best Results: After cleansing, simply smooth into your face and neck with your fingertips, avoiding your eyes. No7 Protect and Perfect Intense ADVANCED Eye Cream 5ml e 0.16 US Fl.Oz. Smooth the appearance of deep lines and wrinkles and help delay new ones with No7's ADVANCED protecting and renewing eye cream. Supercharge by Matrixyl 3000 Plus TM, our unique and most concentrated peptide technology to target deep lines and wrinkles. Especially designed for the delicate area around your eyes, it targets troublesome wrinkles whilst visibly improving dark shadows and puffiness. Contains No7's best antioxidant protection, Double Defence technology. For Best Results: Use morning and evening, dot around eyes and gently blend around contours.</Description>
</NDC>
<NDC>
<NDCCode>11704-107-01</NDCCode>
<PackageDescription>.3 mL in 1 SYRINGE, GLASS (11704-107-01) </PackageDescription>
<NDC11Code>11704-0107-01</NDC11Code>
<ProductNDC>11704-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropen Auto-injector</ProprietaryName>
<NonProprietaryName>Atropine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20040917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017106</ApplicationNumber>
<LabelerName>Meridian Medical Technologies LLC</LabelerName>
<SubstanceName>ATROPINE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
<Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>12027-107-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (12027-107-02) > 15 g in 1 CONTAINER (12027-107-01) </PackageDescription>
<NDC11Code>12027-0107-02</NDC11Code>
<ProductNDC>12027-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Megacushion Foundation</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180105</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Markwins Beauty Products, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.96; 6.73; 7; 2.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180111</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13107-107-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-107-01) </PackageDescription>
<NDC11Code>13107-0107-01</NDC11Code>
<ProductNDC>13107-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205814</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of hydromorphone hydrochloride is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. Tablets (for oral administration) contain: 2 mg hydromorphone hydrochloride, USP (light orange to orange colored, mottled, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, D&C Yellow #10 aluminum lake, and D&C Red #30 aluminum lake/Helendon Pink aluminum lake.4 mg hydromorphone hydrochloride, USP (light yellow to yellow colored, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10 aluminum lake.8 mg hydromorphone hydrochloride, USP (white to off-white, round, flat-faced beveled edge tablet) and the excipients anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>13746-107-01</NDCCode>
<PackageDescription>25 kg in 1 CONTAINER (13746-107-01) </PackageDescription>
<NDC11Code>13746-0107-01</NDC11Code>
<ProductNDC>13746-107</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Chlorcyclizine Hydrochloride Bp</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110504</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Srikem Laboratories Pvt. Ltd.</LabelerName>
<SubstanceName>CHLORCYCLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-11-03</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-MAY-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13925-107-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13925-107-01) </PackageDescription>
<NDC11Code>13925-0107-01</NDC11Code>
<ProductNDC>13925-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methenamine Mandelate</ProprietaryName>
<NonProprietaryName>Methenamine Mandelate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Seton Pharmaceuticals</LabelerName>
<SubstanceName>METHENAMINE MANDELATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. When used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. Prophylactic Use Rationale: Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of methenamine mandelate can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis. Therapeutic Use Rationale: Methenamine mandelate helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Methenamine mandelate should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of methenamine mandelate.</IndicationAndUsage>
<Description>Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets. Methenamine mandelate tablets contain 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and tItanium dioxide.</Description>
</NDC>
</NDCList>