{
"NDC": [
{
"NDCCode": "58406-445-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-445-04) / 1 mL in 1 SYRINGE (58406-445-01) ",
"NDC11Code": "58406-0445-04",
"ProductNDC": "58406-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20051110",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20051110",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "13537-445-04",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (13537-445-04) > 5 g in 1 BOTTLE, PLASTIC (13537-445-03)",
"NDC11Code": "13537-0445-04",
"ProductNDC": "13537-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 35plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against First Signs Of Aging Day - Normal To Dry Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "49349-445-04",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (49349-445-04)",
"NDC11Code": "49349-0445-04",
"ProductNDC": "49349-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070974",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "62499-445-11",
"PackageDescription": "1 TUBE in 1 CARTON (62499-445-11) > 50 g in 1 TUBE (62499-445-04)",
"NDC11Code": "62499-0445-11",
"ProductNDC": "62499-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf 15 Anti-shine Moisturizing",
"NonProprietaryName": "Octinoxate And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laboratoire Dr Renaud Inc.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "7.77; .1",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "84756-445-04",
"PackageDescription": "50 g in 1 BOX (84756-445-04) ",
"NDC11Code": "84756-0445-04",
"ProductNDC": "84756-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Firming",
"NonProprietaryName": "Trstay Firming",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241125",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241125",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-445-04",
"PackageDescription": "100 g in 1 BOX (84827-445-04) ",
"NDC11Code": "84827-0445-04",
"ProductNDC": "84827-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Night Cream Moisturizer",
"NonProprietaryName": "Trstay Night Cream Moisturizer",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "58406-010-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-010-04) / .5 mL in 1 SYRINGE (58406-010-01) ",
"NDC11Code": "58406-0010-04",
"ProductNDC": "58406-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190607",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-021-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-021-04) / 1 mL in 1 SYRINGE (58406-021-01) ",
"NDC11Code": "58406-0021-04",
"ProductNDC": "58406-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190607",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-032-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-032-04) / 1 mL in 1 SYRINGE (58406-032-01) ",
"NDC11Code": "58406-0032-04",
"ProductNDC": "58406-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190607",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-044-04",
"PackageDescription": "4 CARTRIDGE in 1 CARTON (58406-044-04) / 1 mL in 1 CARTRIDGE (58406-044-01) ",
"NDC11Code": "58406-0044-04",
"ProductNDC": "58406-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190607",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-055-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-04) / .5 mL in 1 VIAL, SINGLE-DOSE (58406-055-01) ",
"NDC11Code": "58406-0055-04",
"ProductNDC": "58406-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-435-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-435-04) / 1 mL in 1 SYRINGE (58406-435-01) ",
"NDC11Code": "58406-0435-04",
"ProductNDC": "58406-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20051006",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20051006",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-446-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-446-04) / 1 mL in 1 SYRINGE (58406-446-01) ",
"NDC11Code": "58406-0446-04",
"ProductNDC": "58406-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N"
},
{
"NDCCode": "58406-455-04",
"PackageDescription": "4 SYRINGE in 1 CARTON (58406-455-04) / .5 mL in 1 SYRINGE (58406-455-01) ",
"NDC11Code": "58406-0455-04",
"ProductNDC": "58406-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20051110",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20051110",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "58406-456-04",
"PackageDescription": "4 CARTRIDGE in 1 CARTON (58406-456-04) / 1 mL in 1 CARTRIDGE (58406-456-01) ",
"NDC11Code": "58406-0456-04",
"ProductNDC": "58406-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enbrel",
"NonProprietaryName": "Etanercept",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103795",
"LabelerName": "Immunex Corporation",
"SubstanceName": "ETANERCEPT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170929",
"SamplePackage": "N",
"IndicationAndUsage": "Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).",
"Description": "Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2."
},
{
"NDCCode": "12541-102-12",
"PackageDescription": "445 mL in 1 BOTTLE (12541-102-12) ",
"NDC11Code": "12541-0102-12",
"ProductNDC": "12541-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lifebuoy Hand Sanitizer",
"ProprietaryNameSuffix": "70 Percent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "MILOTT LABORATORIES COMPANY LIMITED",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N"
},
{
"NDCCode": "29300-445-19",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (29300-445-19) ",
"NDC11Code": "29300-0445-19",
"ProductNDC": "29300-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219593",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "30142-445-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (30142-445-91)",
"NDC11Code": "30142-0445-91",
"ProductNDC": "30142-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "31722-445-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-445-30) ",
"NDC11Code": "31722-0445-30",
"ProductNDC": "31722-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209591",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablet may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies ( 14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablet compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablet 10 mg/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP)< 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP)< 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablet 10 mg/40 mg.",
"Description": "Amlodipine and olmesartan medoxomil USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its molecular formula is C 26H 31ClN 2O 8S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet USP contains amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.6, respectively. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg tablet also contains iron oxide black, iron oxide red and iron oxide yellow. The botanical source for pregelatinized starch is corn starch. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-445-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (31722-445-90) ",
"NDC11Code": "31722-0445-90",
"ProductNDC": "31722-445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209591",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablet may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies ( 14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablet compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablet 10 mg/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP)< 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP)< 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablet 10 mg/40 mg.",
"Description": "Amlodipine and olmesartan medoxomil USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its molecular formula is C 26H 31ClN 2O 8S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet USP contains amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.6, respectively. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg tablet also contains iron oxide black, iron oxide red and iron oxide yellow. The botanical source for pregelatinized starch is corn starch. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "37808-445-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (37808-445-91)",
"NDC11Code": "37808-0445-91",
"ProductNDC": "37808-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140320",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "H E B",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43598-445-28",
"PackageDescription": "56 PATCH in 1 CARTON (43598-445-28) > 1 KIT in 1 PATCH (43598-445-56) ",
"NDC11Code": "43598-0445-28",
"ProductNDC": "43598-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System",
"NonProprietaryName": "Nicotine",
"DosageFormName": "KIT",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150514",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "49035-445-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (49035-445-91)",
"NDC11Code": "49035-0445-91",
"ProductNDC": "49035-445",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140205",
"EndMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49281-026-50",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-026-50) / .5 mL in 1 SYRINGE (49281-026-88) ",
"NDC11Code": "49281-0026-50",
"ProductNDC": "49281-026",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Nuvaxovid 2026-27",
"NonProprietaryName": "Nvx-cov2928",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260827",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125817",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "NVX-COV2928",
"StrengthNumber": "5",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260827",
"SamplePackage": "N",
"IndicationAndUsage": "NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), Tergitol (NP9) (< 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "50069-104-12",
"PackageDescription": "445 mL in 1 BOTTLE (50069-104-12) ",
"NDC11Code": "50069-0104-12",
"ProductNDC": "50069-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lifebuoy Hand Sanitizer",
"ProprietaryNameSuffix": "75 Percent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "UNILEVER ASIA PRIVATE LIMITED",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "50069-107-12",
"PackageDescription": "445 mL in 1 BOTTLE (50069-107-12) ",
"NDC11Code": "50069-0107-12",
"ProductNDC": "50069-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lifebuoy Hand Sanitizer",
"ProprietaryNameSuffix": "70 Percent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "UNILEVER ASIA PRIVATE LIMITED",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200604",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "50090-0503-4",
"PackageDescription": "200 TABLET in 1 BOTTLE (50090-0503-4) ",
"NDC11Code": "50090-0503-04",
"ProductNDC": "50090-0503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074223",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160629",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid."
},
{
"NDCCode": "50090-0505-4",
"PackageDescription": "200 TABLET in 1 BOTTLE (50090-0505-4) ",
"NDC11Code": "50090-0505-04",
"ProductNDC": "50090-0505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075795",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-4297-0",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-0) ",
"NDC11Code": "50090-4297-00",
"ProductNDC": "50090-4297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170512",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206928",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190513",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide."
},
{
"NDCCode": "50090-4297-2",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-2) ",
"NDC11Code": "50090-4297-02",
"ProductNDC": "50090-4297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170512",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206928",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190513",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58406-445-04</NDCCode>
<PackageDescription>4 SYRINGE in 1 CARTON (58406-445-04) / 1 mL in 1 SYRINGE (58406-445-01) </PackageDescription>
<NDC11Code>58406-0445-04</NDC11Code>
<ProductNDC>58406-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enbrel</ProprietaryName>
<NonProprietaryName>Etanercept</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20051110</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103795</ApplicationNumber>
<LabelerName>Immunex Corporation</LabelerName>
<SubstanceName>ETANERCEPT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of. Adult patients with: 1 Rheumatoid Arthritis (RA) (1.1), 2 Psoriatic Arthritis (PsA) (1.3), 3 Ankylosing Spondylitis (AS) (1.4), 4 Plaque Psoriasis (PsO) (1.5).</IndicationAndUsage>
<Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
</NDC>
<NDC>
<NDCCode>13537-445-04</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (13537-445-04) > 5 g in 1 BOTTLE, PLASTIC (13537-445-03)</PackageDescription>
<NDC11Code>13537-0445-04</NDC11Code>
<ProductNDC>13537-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 35plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against First Signs Of Aging Day - Normal To Dry Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-445-04</NDCCode>
<PackageDescription>14 TABLET in 1 BLISTER PACK (49349-445-04)</PackageDescription>
<NDC11Code>49349-0445-04</NDC11Code>
<ProductNDC>49349-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070974</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>62499-445-11</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62499-445-11) > 50 g in 1 TUBE (62499-445-04)</PackageDescription>
<NDC11Code>62499-0445-11</NDC11Code>
<ProductNDC>62499-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf 15 Anti-shine Moisturizing</ProprietaryName>
<NonProprietaryName>Octinoxate And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laboratoire Dr Renaud Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7.77; .1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84756-445-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84756-445-04) </PackageDescription>
<NDC11Code>84756-0445-04</NDC11Code>
<ProductNDC>84756-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Firming</ProprietaryName>
<NonProprietaryName>Trstay Firming</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-445-04</NDCCode>
<PackageDescription>100 g in 1 BOX (84827-445-04) </PackageDescription>
<NDC11Code>84827-0445-04</NDC11Code>
<ProductNDC>84827-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Night Cream Moisturizer</ProprietaryName>
<NonProprietaryName>Trstay Night Cream Moisturizer</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58406-010-04</NDCCode>
<PackageDescription>4 SYRINGE in 1 CARTON (58406-010-04) / .5 mL in 1 SYRINGE (58406-010-01) </PackageDescription>
<NDC11Code>58406-0010-04</NDC11Code>
<ProductNDC>58406-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enbrel</ProprietaryName>
<NonProprietaryName>Etanercept</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190607</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103795</ApplicationNumber>
<LabelerName>Immunex Corporation</LabelerName>
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<Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
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<Description>Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Enbrel (etanercept) Injection in the single-dose prefilled syringe, the single-dose prefilled SureClick autoinjector and the single-dose vial is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2. Enbrel (etanercept) for Injection is supplied in a multiple-dose vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-dose, clear, and colorless solution 1 mL containing 25 mg of Enbrel, with a pH of 7.4 ± 0.3. Enbrel (etanercept) Injection in the Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector is clear and colorless, sterile, preservative-free solution, and is formulated at pH 6.3 ± 0.2.</Description>
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<ProductNDC>29300-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219593</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
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<NDCCode>30142-445-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (30142-445-91)</PackageDescription>
<NDC11Code>30142-0445-91</NDC11Code>
<ProductNDC>30142-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>31722-445-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-445-30) </PackageDescription>
<NDC11Code>31722-0445-30</NDC11Code>
<ProductNDC>31722-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209591</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablet may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies ( 14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablet compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablet 10 mg/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP)< 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP)< 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablet 10 mg/40 mg.</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its molecular formula is C 26H 31ClN 2O 8S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet USP contains amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.6, respectively. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg tablet also contains iron oxide black, iron oxide red and iron oxide yellow. The botanical source for pregelatinized starch is corn starch. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-445-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (31722-445-90) </PackageDescription>
<NDC11Code>31722-0445-90</NDC11Code>
<ProductNDC>31722-445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209591</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablet may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies ( 14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablet compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablet 10 mg/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP)< 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Figure Systolic Blood Pressure (SBP)< 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP)< 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablet 5 mg/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablet 10 mg/40 mg.</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil USP provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its molecular formula is C 26H 31ClN 2O 8S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet USP contains amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.6, respectively. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg tablet also contains iron oxide black, iron oxide red and iron oxide yellow. The botanical source for pregelatinized starch is corn starch. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>37808-445-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (37808-445-91)</PackageDescription>
<NDC11Code>37808-0445-91</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140320</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
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<PackageDescription>56 PATCH in 1 CARTON (43598-445-28) > 1 KIT in 1 PATCH (43598-445-56) </PackageDescription>
<NDC11Code>43598-0445-28</NDC11Code>
<ProductNDC>43598-445</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (49035-445-91)</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140205</StartMarketingDate>
<EndMarketingDate>20180101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>49281-026-50</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-026-50) / .5 mL in 1 SYRINGE (49281-026-88) </PackageDescription>
<NDC11Code>49281-0026-50</NDC11Code>
<ProductNDC>49281-026</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Nuvaxovid 2026-27</ProprietaryName>
<NonProprietaryName>Nvx-cov2928</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260827</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125817</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>NVX-COV2928</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), Tergitol (NP9) (< 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50069-104-12</NDCCode>
<PackageDescription>445 mL in 1 BOTTLE (50069-104-12) </PackageDescription>
<NDC11Code>50069-0104-12</NDC11Code>
<ProductNDC>50069-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lifebuoy Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>75 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>UNILEVER ASIA PRIVATE LIMITED</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50069-107-12</NDCCode>
<PackageDescription>445 mL in 1 BOTTLE (50069-107-12) </PackageDescription>
<NDC11Code>50069-0107-12</NDC11Code>
<ProductNDC>50069-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lifebuoy Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200604</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>UNILEVER ASIA PRIVATE LIMITED</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0503-4</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (50090-0503-4) </PackageDescription>
<NDC11Code>50090-0503-04</NDC11Code>
<ProductNDC>50090-0503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074223</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>50090-0505-4</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (50090-0505-4) </PackageDescription>
<NDC11Code>50090-0505-04</NDC11Code>
<ProductNDC>50090-0505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075795</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-4297-0</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-0) </PackageDescription>
<NDC11Code>50090-4297-00</NDC11Code>
<ProductNDC>50090-4297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170512</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206928</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190513</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide.</Description>
</NDC>
<NDC>
<NDCCode>50090-4297-2</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4297-2) </PackageDescription>
<NDC11Code>50090-4297-02</NDC11Code>
<ProductNDC>50090-4297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170512</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206928</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190513</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide extended-release tablets (glipizide) is an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21 H27 N5 O4 S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol. System Components and Performance. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide.</Description>
</NDC>
</NDCList>