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"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
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"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
},
{
"NDCCode": "55513-482-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (55513-482-02) / .4 mL in 1 SYRINGE",
"NDC11Code": "55513-0482-02",
"ProductNDC": "55513-482",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amjevita",
"NonProprietaryName": "Adalimumab-atto",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761024",
"LabelerName": "Amgen, Inc",
"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": "20230814",
"SamplePackage": "N",
"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2."
},
{
"NDCCode": "55513-488-02",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) ",
"NDC11Code": "55513-0488-02",
"ProductNDC": "55513-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55513-509-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (55513-509-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-509-01) ",
"NDC11Code": "55513-0509-02",
"ProductNDC": "55513-509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evenity",
"NonProprietaryName": "Romosozumab-aqqg",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761062",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ROMOSOZUMAB",
"StrengthNumber": "105",
"StrengthUnit": "mg/1.17mL",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).",
"Description": "Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2."
},
{
"NDCCode": "55513-760-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (55513-760-02) / 1 mL in 1 SYRINGE",
"NDC11Code": "55513-0760-02",
"ProductNDC": "55513-760",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Repatha",
"NonProprietaryName": "Evolocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125522",
"LabelerName": "Amgen, Inc",
"SubstanceName": "EVOLOCUMAB",
"StrengthNumber": "140",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
"IndicationAndUsage": "REPATHA is indicated: 1 In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization, 2 As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C, 3 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C, 4 As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C.",
"Description": "Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe and single-dose prefilled SureClick® autoinjector contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0. Each single-dose Pushtronex® system (on-body infusor with prefilled cartridge) delivers a 3.5 mL solution containing 420 mg evolocumab, acetate (4.2 mg), polysorbate 80 (0.35 mg), proline (89 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0."
},
{
"NDCCode": "55513-840-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (55513-840-02) > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "55513-0840-02",
"ProductNDC": "55513-840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aimovig",
"NonProprietaryName": "Erenumab-aooe",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761077",
"LabelerName": "Amgen Inc",
"SubstanceName": "ERENUMAB",
"StrengthNumber": "70",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180522",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "55513-841-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (55513-841-02) > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "55513-0841-02",
"ProductNDC": "55513-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aimovig",
"NonProprietaryName": "Erenumab-aooe",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761077",
"LabelerName": "Amgen Inc",
"SubstanceName": "ERENUMAB",
"StrengthNumber": "70",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180522",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "55513-880-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (55513-880-02) / 1.17 mL in 1 SYRINGE (55513-880-01) ",
"NDC11Code": "55513-0880-02",
"ProductNDC": "55513-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evenity",
"NonProprietaryName": "Romosozumab-aqqg",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190409",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761062",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ROMOSOZUMAB",
"StrengthNumber": "105",
"StrengthUnit": "mg/1.17mL",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190409",
"SamplePackage": "N",
"IndicationAndUsage": "EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).",
"Description": "Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2."
},
{
"NDCCode": "55513-998-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (55513-998-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-998-01) ",
"NDC11Code": "55513-0998-02",
"ProductNDC": "55513-998",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evenity",
"NonProprietaryName": "Romosozumab-aqqg",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761062",
"LabelerName": "Amgen, Inc",
"SubstanceName": "ROMOSOZUMAB",
"StrengthNumber": "105",
"StrengthUnit": "mg/1.17mL",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).",
"Description": "Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2."
},
{
"NDCCode": "13537-479-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-479-02) > 4 g in 1 TUBE (13537-479-01)",
"NDC11Code": "13537-0479-02",
"ProductNDC": "13537-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(rojo Deseo) - Red",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "24236-479-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24236-479-02) ",
"NDC11Code": "24236-0479-02",
"ProductNDC": "24236-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086066",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20080930",
"SamplePackage": "N"
},
{
"NDCCode": "41520-479-02",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (41520-479-02)",
"NDC11Code": "41520-0479-02",
"ProductNDC": "41520-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care One",
"ProprietaryNameSuffix": "Lemon Verbena",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130214",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AMERICAN SALES COMPANY",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "650",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "49349-479-02",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (49349-479-02)",
"NDC11Code": "49349-0479-02",
"ProductNDC": "49349-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine Hydrochloride",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-04-11"
},
{
"NDCCode": "51346-479-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (51346-479-02) > 1 g in 1 CONTAINER (51346-479-01)",
"NDC11Code": "51346-0479-02",
"ProductNDC": "51346-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Intense Cover 3 In 1 Strobing Foundation 02 Natural Beige A",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": ".07",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "52125-479-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-479-02)",
"NDC11Code": "52125-0479-02",
"ProductNDC": "52125-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150407",
"EndMarketingDate": "20170719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "53489-479-02",
"PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02) ",
"NDC11Code": "53489-0479-02",
"ProductNDC": "53489-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072051",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "SULINDAC",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.",
"Description": "Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are."
},
{
"NDCCode": "57297-479-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (57297-479-02)",
"NDC11Code": "57297-0479-02",
"ProductNDC": "57297-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "61037-479-02",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (61037-479-02) ",
"NDC11Code": "61037-0479-02",
"ProductNDC": "61037-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090191",
"LabelerName": "BAJAJ MEDICAL, LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
"NDCCode": "61786-479-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61786-479-02)",
"NDC11Code": "61786-0479-02",
"ProductNDC": "61786-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201745",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "63148-479-02",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (63148-479-02)",
"NDC11Code": "63148-0479-02",
"ProductNDC": "63148-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hdx Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160818",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Apollo Health and Beauty Care",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "700",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help reduce bacteria on the skin."
},
{
"NDCCode": "63545-479-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-479-02) ",
"NDC11Code": "63545-0479-02",
"ProductNDC": "63545-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chenopodium Anthelminticum",
"NonProprietaryName": "Chenopodium Anthelminticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "DYSPHANIA AMBROSIOIDES WHOLE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220511",
"SamplePackage": "N"
},
{
"NDCCode": "63824-479-02",
"PackageDescription": "251 mL in 1 BOTTLE (63824-479-02)",
"NDC11Code": "63824-0479-02",
"ProductNDC": "63824-479",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lysol",
"ProprietaryNameSuffix": "No-touch",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "68180-479-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68180-479-02) ",
"NDC11Code": "68180-0479-02",
"ProductNDC": "68180-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078103",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070614",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "70072-002-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70072-002-02) > 479.39 g in 1 CONTAINER (70072-002-01)",
"NDC11Code": "70072-0002-02",
"ProductNDC": "70072-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elf Color",
"NonProprietaryName": "P-phenylenediamine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "giod Co.",
"SubstanceName": "P-PHENYLENEDIAMINE",
"StrengthNumber": "9.58",
"StrengthUnit": "g/479.39g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Shampoo and dry hair before useApply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)Rinse completely and dry hairApply second solution and rinse thoroughly till water runs clear and then shampoo and condition."
},
{
"NDCCode": "70072-003-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70072-003-02) > 479.39 g in 1 CONTAINER (70072-003-01)",
"NDC11Code": "70072-0003-02",
"ProductNDC": "70072-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elf Perm",
"NonProprietaryName": "Panthenol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "giod Co.",
"SubstanceName": "PANTHENOL",
"StrengthNumber": ".47",
"StrengthUnit": "g/479.39g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Shampoo and remove excessive moisture from hair with a towelApply the first solution and roll hair in curlersAllow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed)Apply second solution and rinse."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55513-479-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (55513-479-02) / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0479-02</NDC11Code>
<ProductNDC>55513-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amjevita</ProprietaryName>
<NonProprietaryName>Adalimumab-atto</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761024</ApplicationNumber>
<LabelerName>Amgen, Inc</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>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-479-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (55513-479-01) / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0479-01</NDC11Code>
<ProductNDC>55513-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amjevita</ProprietaryName>
<NonProprietaryName>Adalimumab-atto</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761024</ApplicationNumber>
<LabelerName>Amgen, Inc</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>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto 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. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-488-02</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) </PackageDescription>
<NDC11Code>55513-0488-02</NDC11Code>
<ProductNDC>55513-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55513-509-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (55513-509-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-509-01) </PackageDescription>
<NDC11Code>55513-0509-02</NDC11Code>
<ProductNDC>55513-509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evenity</ProprietaryName>
<NonProprietaryName>Romosozumab-aqqg</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761062</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ROMOSOZUMAB</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1.17mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).</IndicationAndUsage>
<Description>Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-760-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (55513-760-02) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>55513-0760-02</NDC11Code>
<ProductNDC>55513-760</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Repatha</ProprietaryName>
<NonProprietaryName>Evolocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125522</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>EVOLOCUMAB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REPATHA is indicated: 1 In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization, 2 As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C, 3 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C, 4 As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C.</IndicationAndUsage>
<Description>Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL single-dose prefilled syringe and single-dose prefilled SureClick® autoinjector contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0. Each single-dose Pushtronex® system (on-body infusor with prefilled cartridge) delivers a 3.5 mL solution containing 420 mg evolocumab, acetate (4.2 mg), polysorbate 80 (0.35 mg), proline (89 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0.</Description>
</NDC>
<NDC>
<NDCCode>55513-840-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (55513-840-02) > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>55513-0840-02</NDC11Code>
<ProductNDC>55513-840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aimovig</ProprietaryName>
<NonProprietaryName>Erenumab-aooe</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761077</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>ERENUMAB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180522</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55513-841-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (55513-841-02) > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>55513-0841-02</NDC11Code>
<ProductNDC>55513-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aimovig</ProprietaryName>
<NonProprietaryName>Erenumab-aooe</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761077</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>ERENUMAB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180522</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55513-880-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (55513-880-02) / 1.17 mL in 1 SYRINGE (55513-880-01) </PackageDescription>
<NDC11Code>55513-0880-02</NDC11Code>
<ProductNDC>55513-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evenity</ProprietaryName>
<NonProprietaryName>Romosozumab-aqqg</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190409</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761062</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ROMOSOZUMAB</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1.17mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).</IndicationAndUsage>
<Description>Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-998-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (55513-998-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-998-01) </PackageDescription>
<NDC11Code>55513-0998-02</NDC11Code>
<ProductNDC>55513-998</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evenity</ProprietaryName>
<NonProprietaryName>Romosozumab-aqqg</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761062</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>ROMOSOZUMAB</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1.17mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. (1). Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (1.2).</IndicationAndUsage>
<Description>Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe. Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.</Description>
</NDC>
<NDC>
<NDCCode>13537-479-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-479-02) > 4 g in 1 TUBE (13537-479-01)</PackageDescription>
<NDC11Code>13537-0479-02</NDC11Code>
<ProductNDC>13537-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(rojo Deseo) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24236-479-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24236-479-02) </PackageDescription>
<NDC11Code>24236-0479-02</NDC11Code>
<ProductNDC>24236-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086066</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-479-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (41520-479-02)</PackageDescription>
<NDC11Code>41520-0479-02</NDC11Code>
<ProductNDC>41520-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care One</ProprietaryName>
<ProprietaryNameSuffix>Lemon Verbena</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AMERICAN SALES COMPANY</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-479-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (49349-479-02)</PackageDescription>
<NDC11Code>49349-0479-02</NDC11Code>
<ProductNDC>49349-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>51346-479-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51346-479-02) > 1 g in 1 CONTAINER (51346-479-01)</PackageDescription>
<NDC11Code>51346-0479-02</NDC11Code>
<ProductNDC>51346-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Intense Cover 3 In 1 Strobing Foundation 02 Natural Beige A</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52125-479-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-479-02)</PackageDescription>
<NDC11Code>52125-0479-02</NDC11Code>
<ProductNDC>52125-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150407</StartMarketingDate>
<EndMarketingDate>20170719</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>53489-479-02</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02) </PackageDescription>
<NDC11Code>53489-0479-02</NDC11Code>
<ProductNDC>53489-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072051</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
</NDC>
<NDC>
<NDCCode>57297-479-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (57297-479-02)</PackageDescription>
<NDC11Code>57297-0479-02</NDC11Code>
<ProductNDC>57297-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>61037-479-02</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (61037-479-02) </PackageDescription>
<NDC11Code>61037-0479-02</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>61786-479-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61786-479-02)</PackageDescription>
<NDC11Code>61786-0479-02</NDC11Code>
<ProductNDC>61786-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201745</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>63148-479-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (63148-479-02)</PackageDescription>
<NDC11Code>63148-0479-02</NDC11Code>
<ProductNDC>63148-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hdx Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-479-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-479-02) </PackageDescription>
<NDC11Code>63545-0479-02</NDC11Code>
<ProductNDC>63545-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chenopodium Anthelminticum</ProprietaryName>
<NonProprietaryName>Chenopodium Anthelminticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>DYSPHANIA AMBROSIOIDES WHOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63824-479-02</NDCCode>
<PackageDescription>251 mL in 1 BOTTLE (63824-479-02)</PackageDescription>
<NDC11Code>63824-0479-02</NDC11Code>
<ProductNDC>63824-479</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lysol</ProprietaryName>
<ProprietaryNameSuffix>No-touch</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-479-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68180-479-02) </PackageDescription>
<NDC11Code>68180-0479-02</NDC11Code>
<ProductNDC>68180-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078103</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets USP are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia.In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>70072-002-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (70072-002-02) > 479.39 g in 1 CONTAINER (70072-002-01)</PackageDescription>
<NDC11Code>70072-0002-02</NDC11Code>
<ProductNDC>70072-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elf Color</ProprietaryName>
<NonProprietaryName>P-phenylenediamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>giod Co.</LabelerName>
<SubstanceName>P-PHENYLENEDIAMINE</SubstanceName>
<StrengthNumber>9.58</StrengthNumber>
<StrengthUnit>g/479.39g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Shampoo and dry hair before useApply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)Rinse completely and dry hairApply second solution and rinse thoroughly till water runs clear and then shampoo and condition.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70072-003-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (70072-003-02) > 479.39 g in 1 CONTAINER (70072-003-01)</PackageDescription>
<NDC11Code>70072-0003-02</NDC11Code>
<ProductNDC>70072-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elf Perm</ProprietaryName>
<NonProprietaryName>Panthenol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>giod Co.</LabelerName>
<SubstanceName>PANTHENOL</SubstanceName>
<StrengthNumber>.47</StrengthNumber>
<StrengthUnit>g/479.39g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Shampoo and remove excessive moisture from hair with a towelApply the first solution and roll hair in curlersAllow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed)Apply second solution and rinse.</IndicationAndUsage>
</NDC>
</NDCList>