{
"NDC": [
{
"NDCCode": "14783-206-28",
"PackageDescription": "1 TUBE in 1 BOX (14783-206-28) > 3 mL in 1 TUBE (14783-206-27)",
"NDC11Code": "14783-0206-28",
"ProductNDC": "14783-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
"ProprietaryNameSuffix": "(medium 7) - Brown",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-206-26",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-206-26) > 30 mL in 1 BOTTLE (14783-206-25)",
"NDC11Code": "14783-0206-26",
"ProductNDC": "14783-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
"ProprietaryNameSuffix": "(medium 7) - Brown",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-272-28",
"PackageDescription": "1 TUBE in 1 BOX (14783-272-28) > 3 mL in 1 TUBE (14783-272-27)",
"NDC11Code": "14783-0272-28",
"ProductNDC": "14783-272",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Maximum Comfort And Long-lasting Foundation Spf 10",
"ProprietaryNameSuffix": "(medium 7) - Brown",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".016",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-606-28",
"PackageDescription": "1 TUBE in 1 BOX (14783-606-28) > 3 g in 1 TUBE (14783-606-27)",
"NDC11Code": "14783-0606-28",
"ProductNDC": "14783-606",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "(medium 7) - Brown",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-884-28",
"PackageDescription": "1 TUBE in 1 BOX (14783-884-28) > 4 g in 1 TUBE (14783-884-27)",
"NDC11Code": "14783-0884-28",
"ProductNDC": "14783-884",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Rouge Amplifier",
"ProprietaryNameSuffix": "Amplifying Spf 15 (malbec) - Brown",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".072",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-904-28",
"PackageDescription": "1 TUBE in 1 BOX (14783-904-28) > 4 g in 1 TUBE (14783-904-27)",
"NDC11Code": "14783-0904-28",
"ProductNDC": "14783-904",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Hydratess",
"ProprietaryNameSuffix": "Long-lasting Intense Moisturizing Spf 20 (mandarine) - Orange",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".071; .016",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13537-206-28",
"PackageDescription": "1 TUBE in 1 BOX (13537-206-28) > 3 mL in 1 TUBE (13537-206-27)",
"NDC11Code": "13537-0206-28",
"ProductNDC": "13537-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Filling Effect Foundation Spf 10",
"ProprietaryNameSuffix": "(medium 7) - Brown",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "55289-206-28",
"PackageDescription": "28 TABLET in 1 BOTTLE, PLASTIC (55289-206-28)",
"NDC11Code": "55289-0206-28",
"ProductNDC": "55289-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064071",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-23"
},
{
"NDCCode": "63402-206-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-206-28) / 7 TABLET in 1 BLISTER PACK (63402-206-07) ",
"NDC11Code": "63402-0206-28",
"ProductNDC": "63402-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "66302-206-01",
"PackageDescription": "1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE",
"NDC11Code": "66302-0206-01",
"ProductNDC": "66302-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyvaso",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INHALANT",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022387",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "1.74",
"StrengthUnit": "mg/2.9mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090814",
"SamplePackage": "N",
"IndicationAndUsage": "Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).",
"Description": "Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "66302-206-02",
"PackageDescription": "1 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE",
"NDC11Code": "66302-0206-02",
"ProductNDC": "66302-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyvaso",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INHALANT",
"RouteName": "ORAL",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022387",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "1.74",
"StrengthUnit": "mg/2.9mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090814",
"SamplePackage": "N",
"IndicationAndUsage": "Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).",
"Description": "Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "73069-206-28",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-206-28) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0206-28",
"ProductNDC": "73069-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-hair",
"NonProprietaryName": "Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)",
"StrengthNumber": "31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "83114-206-28",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (83114-206-28) ",
"NDC11Code": "83114-0206-28",
"ProductNDC": "83114-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xcopri Titration Pack 150 Mg, 200 Mg",
"NonProprietaryName": "Cenobamate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200312",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212839",
"LabelerName": "PCI Pharma Services Canada, Inc.",
"SubstanceName": "CENOBAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/2001",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200312",
"SamplePackage": "N",
"IndicationAndUsage": "XCOPRI is indicated for the treatment of partial-onset seizures in adult patients."
},
{
"NDCCode": "63629-8519-1",
"PackageDescription": "480 mL in 1 BOTTLE (63629-8519-1) ",
"NDC11Code": "63629-8519-01",
"ProductNDC": "63629-8519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "63629-8521-1",
"PackageDescription": "60 mL in 1 BOTTLE (63629-8521-1) ",
"NDC11Code": "63629-8521-01",
"ProductNDC": "63629-8521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065422",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "66689-008-02",
"PackageDescription": "60 mL in 1 BOTTLE (66689-008-02) ",
"NDC11Code": "66689-0008-02",
"ProductNDC": "66689-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "66689-008-08",
"PackageDescription": "237 mL in 1 BOTTLE (66689-008-08) ",
"NDC11Code": "66689-0008-08",
"ProductNDC": "66689-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "66689-008-16",
"PackageDescription": "480 mL in 1 BOTTLE (66689-008-16) ",
"NDC11Code": "66689-0008-16",
"ProductNDC": "66689-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "66689-037-50",
"PackageDescription": "5 TRAY in 1 CASE (66689-037-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-037-01) ",
"NDC11Code": "66689-0037-50",
"ProductNDC": "66689-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100510",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100510",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "66689-037-99",
"PackageDescription": "10 TRAY in 1 CASE (66689-037-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-037-01) ",
"NDC11Code": "66689-0037-99",
"ProductNDC": "66689-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100510",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064142",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100510",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF."
},
{
"NDCCode": "0078-0639-41",
"PackageDescription": "2 mL in 1 CARTON (0078-0639-41) ",
"NDC11Code": "00078-0639-41",
"ProductNDC": "0078-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150121",
"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-0639-68",
"PackageDescription": "1 mL in 1 CARTON (0078-0639-68) ",
"NDC11Code": "00078-0639-68",
"ProductNDC": "0078-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150121",
"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-0639-97",
"PackageDescription": "1 mL in 1 CARTON (0078-0639-97) ",
"NDC11Code": "00078-0639-97",
"ProductNDC": "0078-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150121",
"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-0639-98",
"PackageDescription": "2 mL in 1 CARTON (0078-0639-98) ",
"NDC11Code": "00078-0639-98",
"ProductNDC": "0078-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150121",
"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-1056-97",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-1056-97) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-1056-97",
"ProductNDC": "0078-1056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
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"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
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"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-1070-68",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-1070-68",
"ProductNDC": "0078-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
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"RouteName": "SUBCUTANEOUS",
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"LabelerName": "Novartis Pharmaceuticals Corporation",
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"Status": "Active",
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"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-1070-96",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-1070-96",
"ProductNDC": "0078-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125504",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "300",
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"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
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"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0078-1168-61",
"PackageDescription": "5 mL in 1 VIAL, GLASS (0078-1168-61) ",
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"ProductNDC": "0078-1168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosentyx",
"NonProprietaryName": "Secukinumab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
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"ApplicationNumber": "BLA761349",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "SECUKINUMAB",
"StrengthNumber": "25",
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"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).",
"Description": "Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8."
},
{
"NDCCode": "0093-8107-98",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0093-8107-98) ",
"NDC11Code": "00093-8107-98",
"ProductNDC": "0093-8107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen And Famotidine",
"NonProprietaryName": "Ibuprofen And Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211278",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FAMOTIDINE; IBUPROFEN",
"StrengthNumber": "26.6; 800",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)].",
"Description": "Ibuprofen and famotidine tablets are supplied as film-coated tablets for oral administration which combine the nonsteroidal anti-inflammatory drug, ibuprofen USP, and the histamine H2-receptor antagonist, famotidine, USP. Ibuprofen, USP is (±)-2-(p-isobutylphenyl)propionic acid. Its chemical formula is C13H18O2 and molecular weight is 206.28. Ibuprofen, USP is a white powder that is very slightly soluble in water (less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Its structural formula is. Famotidine, USP is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]propanimidamide. Its chemical formula is C8H15N7O2S3 and molecular weight is 337.45. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Its structural formula is. Each film-coated tablet contains ibuprofen, USP (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in ibuprofen and famotidine tablets include: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, talc, and titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac."
}
]
}
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<ProprietaryName>Lbel Maximum Comfort And Long-lasting Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(medium 7) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.016</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-606-28</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-606-28) > 3 g in 1 TUBE (14783-606-27)</PackageDescription>
<NDC11Code>14783-0606-28</NDC11Code>
<ProductNDC>14783-606</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>(medium 7) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-884-28</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-884-28) > 4 g in 1 TUBE (14783-884-27)</PackageDescription>
<NDC11Code>14783-0884-28</NDC11Code>
<ProductNDC>14783-884</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 (malbec) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.072</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-904-28</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-904-28) > 4 g in 1 TUBE (14783-904-27)</PackageDescription>
<NDC11Code>14783-0904-28</NDC11Code>
<ProductNDC>14783-904</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Hydratess</ProprietaryName>
<ProprietaryNameSuffix>Long-lasting Intense Moisturizing Spf 20 (mandarine) - Orange</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .016</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-206-28</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-206-28) > 3 mL in 1 TUBE (13537-206-27)</PackageDescription>
<NDC11Code>13537-0206-28</NDC11Code>
<ProductNDC>13537-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Filling Effect Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(medium 7) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-206-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE, PLASTIC (55289-206-28)</PackageDescription>
<NDC11Code>55289-0206-28</NDC11Code>
<ProductNDC>55289-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064071</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>63402-206-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-206-28) / 7 TABLET in 1 BLISTER PACK (63402-206-07) </PackageDescription>
<NDC11Code>63402-0206-28</NDC11Code>
<ProductNDC>63402-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>66302-206-01</NDCCode>
<PackageDescription>1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66302-0206-01</NDC11Code>
<ProductNDC>66302-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyvaso</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022387</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>1.74</StrengthNumber>
<StrengthUnit>mg/2.9mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).</IndicationAndUsage>
<Description>Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
<NDC>
<NDCCode>66302-206-02</NDCCode>
<PackageDescription>1 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66302-0206-02</NDC11Code>
<ProductNDC>66302-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyvaso</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022387</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>1.74</StrengthNumber>
<StrengthUnit>mg/2.9mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tyvaso is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).</IndicationAndUsage>
<Description>Tyvaso is a sterile formulation of treprostinil, a prostacyclin mimetic, intended for administration by oral inhalation using the Tyvaso Inhalation System. Tyvaso is supplied in 2.9 mL low density polyethylene (LDPE) ampules, containing 1.74 mg treprostinil (0.6 mg/mL). Each ampule also contains 18.9 mg sodium chloride, 18.3 mg sodium citrate dihydrate, 0.58 mg sodium hydroxide, 11.7 mg 1 N hydrochloric acid, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
<NDC>
<NDCCode>73069-206-28</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-206-28) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0206-28</NDC11Code>
<ProductNDC>73069-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-hair</ProprietaryName>
<NonProprietaryName>Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)</SubstanceName>
<StrengthNumber>31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83114-206-28</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (83114-206-28) </PackageDescription>
<NDC11Code>83114-0206-28</NDC11Code>
<ProductNDC>83114-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xcopri Titration Pack 150 Mg, 200 Mg</ProprietaryName>
<NonProprietaryName>Cenobamate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200312</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212839</ApplicationNumber>
<LabelerName>PCI Pharma Services Canada, Inc.</LabelerName>
<SubstanceName>CENOBAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/2001</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63629-8519-1</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (63629-8519-1) </PackageDescription>
<NDC11Code>63629-8519-01</NDC11Code>
<ProductNDC>63629-8519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>63629-8521-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (63629-8521-1) </PackageDescription>
<NDC11Code>63629-8521-01</NDC11Code>
<ProductNDC>63629-8521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065422</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>66689-008-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (66689-008-02) </PackageDescription>
<NDC11Code>66689-0008-02</NDC11Code>
<ProductNDC>66689-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>66689-008-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (66689-008-08) </PackageDescription>
<NDC11Code>66689-0008-08</NDC11Code>
<ProductNDC>66689-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>66689-008-16</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (66689-008-16) </PackageDescription>
<NDC11Code>66689-0008-16</NDC11Code>
<ProductNDC>66689-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>66689-037-50</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (66689-037-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-037-01) </PackageDescription>
<NDC11Code>66689-0037-50</NDC11Code>
<ProductNDC>66689-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100510</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100510</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>66689-037-99</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (66689-037-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-037-01) </PackageDescription>
<NDC11Code>66689-0037-99</NDC11Code>
<ProductNDC>66689-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100510</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064142</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100510</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL. Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP. Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.</Description>
</NDC>
<NDC>
<NDCCode>0078-0639-41</NDCCode>
<PackageDescription>2 mL in 1 CARTON (0078-0639-41) </PackageDescription>
<NDC11Code>00078-0639-41</NDC11Code>
<ProductNDC>0078-0639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0078-0639-68</NDCCode>
<PackageDescription>1 mL in 1 CARTON (0078-0639-68) </PackageDescription>
<NDC11Code>00078-0639-68</NDC11Code>
<ProductNDC>0078-0639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0078-0639-97</NDCCode>
<PackageDescription>1 mL in 1 CARTON (0078-0639-97) </PackageDescription>
<NDC11Code>00078-0639-97</NDC11Code>
<ProductNDC>0078-0639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0078-0639-98</NDCCode>
<PackageDescription>2 mL in 1 CARTON (0078-0639-98) </PackageDescription>
<NDC11Code>00078-0639-98</NDC11Code>
<ProductNDC>0078-0639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosentyx</ProprietaryName>
<NonProprietaryName>Secukinumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125504</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>SECUKINUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: 1 moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. (1.1), 2 active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. (1.2), 3 active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. (1.3), 4 active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. (1.4), 5 active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. (1.5), 6 moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. (1.6).</IndicationAndUsage>
<Description>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains. COSENTYX Injection for Subcutaneous Use. COSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX injection is supplied in a single-dose UnoReady pen (300 mg/2 mL) with a 27-gauge fixed ½-inch needle, a single-dose Sensoready pen (150 mg/mL) with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe (150 mg/mL, 75 mg/0.5 mL) with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex. Each COSENTYX UnoReady pen (300 mg/2 mL) contains 300 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (6.206 mg), L-methionine (1.492 mg), polysorbate 80 (0.4 mg), trehalose dihydrate (151.34 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX Sensoready pen or prefilled syringe (150 mg/mL) contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8. Each COSENTYX prefilled syringe (75 mg/0.5 mL) contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX Injection for Intravenous Use. COSENTYX solution is supplied as a sterile, preservative free, clear to opalescent, colorless to slightly yellowish solution in single-dose vials for intravenous infusion after dilution. Each COSENTYX vial (125 mg/5 mL) contains 125 mg of secukinumab formulated in: L-histidine (5.67 mg), L-histidine hydrochloride monohydrate (13.3 mg), L-methionine (3.73 mg), polysorbate 80 (1 mg), trehalose dihydrate (426 mg), and Sterile Water for Injection, USP, at pH of 5.8.</Description>
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<IndicationAndUsage>Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)].</IndicationAndUsage>
<Description>Ibuprofen and famotidine tablets are supplied as film-coated tablets for oral administration which combine the nonsteroidal anti-inflammatory drug, ibuprofen USP, and the histamine H2-receptor antagonist, famotidine, USP. Ibuprofen, USP is (±)-2-(p-isobutylphenyl)propionic acid. Its chemical formula is C13H18O2 and molecular weight is 206.28. Ibuprofen, USP is a white powder that is very slightly soluble in water (less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Its structural formula is. Famotidine, USP is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]propanimidamide. Its chemical formula is C8H15N7O2S3 and molecular weight is 337.45. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Its structural formula is. Each film-coated tablet contains ibuprofen, USP (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in ibuprofen and famotidine tablets include: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, talc, and titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac.</Description>
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