{
"NDC": [
{
"NDCCode": "53738-0713-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (53738-0713-0) > 50 mL in 1 BOTTLE",
"NDC11Code": "53738-0713-00",
"ProductNDC": "53738-0713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roc Multi Correxion 5 In 1 Moisturizer",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Sante Beaute- France",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "20; 40; 40; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "53738-0710-0",
"PackageDescription": "1 TUBE in 1 CARTON (53738-0710-0) > 40 mL in 1 TUBE",
"NDC11Code": "53738-0710-00",
"ProductNDC": "53738-0710",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roc Multi Correxion",
"ProprietaryNameSuffix": "Lift Anti Gravity Day Moisturizer Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"EndMarketingDate": "20160701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Sante Beaute � France",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 12; 50; 17; 30",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "53738-0712-0",
"PackageDescription": "1 TUBE in 1 CARTON (53738-0712-0) > 38 mL in 1 TUBE",
"NDC11Code": "53738-0712-00",
"ProductNDC": "53738-0712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roc Multi Correxion Lift Anti Gravity Day Moisturizer",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120607",
"EndMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Sante Beaute- France",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 120; 50; 17; 30",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120607",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
},
{
"NDCCode": "53738-0714-0",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (53738-0714-0) > 50 mL in 1 BOTTLE, PUMP",
"NDC11Code": "53738-0714-00",
"ProductNDC": "53738-0714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roc Multi Correxion 4 Zone Daily Moisturizer",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121015",
"EndMarketingDate": "20150513",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Sante Beaute- France",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 40; 30",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "53738-9905-0",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (53738-9905-0) > 50 mL in 1 BOTTLE, PUMP",
"NDC11Code": "53738-9905-00",
"ProductNDC": "53738-9905",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roc Multi Correxion",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091210",
"EndMarketingDate": "20151009",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Sante Beaute France",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "25.3; 77.4; 50.3; 25.3",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "15308-0713-0",
"PackageDescription": "25 kg in 1 DRUM (15308-0713-0) ",
"NDC11Code": "15308-0713-00",
"ProductNDC": "15308-0713",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Desonide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19830101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aarti Pharmalabs Limited",
"SubstanceName": "DESONIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-11-09",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-JAN-83"
},
{
"NDCCode": "50090-0713-0",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-0713-0) ",
"NDC11Code": "50090-0713-00",
"ProductNDC": "50090-0713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065256",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2024-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.",
"Description": "Amoxicillin tablets, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45.Each film coated tablet contains 500 mg or 875 mg amoxicillin USP as the trihydrate. The 500 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. The 875 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, D&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "52932-0713-0",
"PackageDescription": "25 kg in 1 DRUM (52932-0713-0) ",
"NDC11Code": "52932-0713-00",
"ProductNDC": "52932-0713",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Moehs Catalana SL",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-03-27",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "29-SEP-09"
},
{
"NDCCode": "57572-0713-0",
"PackageDescription": "5 kg in 1 DRUM (57572-0713-0)",
"NDC11Code": "57572-0713-00",
"ProductNDC": "57572-0713",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Azelastine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20070928",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Esteve Quimica, SA",
"SubstanceName": "AZELASTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2017-12-20",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58624-0713-0",
"PackageDescription": "25 kg in 1 CARTON (58624-0713-0) ",
"NDC11Code": "58624-0713-00",
"ProductNDC": "58624-0713",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Theophylline Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260119",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Shandong Xinhua Pharmaceutical Company Limited",
"SubstanceName": "THEOPHYLLINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-19",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19-JAN-26"
},
{
"NDCCode": "70518-0713-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0713-0) ",
"NDC11Code": "70518-0713-00",
"ProductNDC": "70518-0713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065218",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170825",
"SamplePackage": "N"
},
{
"NDCCode": "0713-0223-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0223-15) / 15 g in 1 TUBE",
"NDC11Code": "00713-0223-15",
"ProductNDC": "0713-0223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089526",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880726",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0223-60",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0223-60) / 60 g in 1 TUBE",
"NDC11Code": "00713-0223-60",
"ProductNDC": "0713-0223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089526",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880726",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0224-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0224-15) / 15 g in 1 TUBE",
"NDC11Code": "00713-0224-15",
"ProductNDC": "0713-0224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089524",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880726",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0224-60",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0224-60) / 60 g in 1 TUBE",
"NDC11Code": "00713-0224-60",
"ProductNDC": "0713-0224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089524",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880726",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0225-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0225-15) > 15 g in 1 TUBE",
"NDC11Code": "00713-0225-15",
"ProductNDC": "0713-0225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089798",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0225-31",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0225-31) > 30 g in 1 TUBE",
"NDC11Code": "00713-0225-31",
"ProductNDC": "0713-0225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089798",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0225-80",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0225-80) > 80 g in 1 TUBE",
"NDC11Code": "00713-0225-80",
"ProductNDC": "0713-0225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089798",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0226-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0226-15) > 15 g in 1 TUBE",
"NDC11Code": "00713-0226-15",
"ProductNDC": "0713-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089797",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0226-80",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0226-80) > 80 g in 1 TUBE",
"NDC11Code": "00713-0226-80",
"ProductNDC": "0713-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089797",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0228-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0228-15) / 15 g in 1 TUBE",
"NDC11Code": "00713-0228-15",
"ProductNDC": "0713-0228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089796",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150910",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0228-31",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0228-31) / 30 g in 1 TUBE",
"NDC11Code": "00713-0228-31",
"ProductNDC": "0713-0228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089796",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241206",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0228-80",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0228-80) / 80 g in 1 TUBE",
"NDC11Code": "00713-0228-80",
"ProductNDC": "0713-0228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089796",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150910",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0229-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0229-15) / 15 g in 1 TUBE",
"NDC11Code": "00713-0229-15",
"ProductNDC": "0713-0229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089795",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150910",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0229-80",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0229-80) / 80 g in 1 TUBE",
"NDC11Code": "00713-0229-80",
"ProductNDC": "0713-0229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089795",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150910",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP."
},
{
"NDCCode": "0713-0317-88",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0713-0317-88) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "00713-0317-88",
"ProductNDC": "0713-0317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070522",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078233",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070522",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be used only under medical supervision as described above. The effectiveness and safety of Ciclopirox Topical Solution, 8%,(Nail Lacquer), in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy,were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. The safety and efficacy of using Ciclopirox Topical Solution, 8%,(Nail Lacquer), daily for greater than 48 weeks have not been established. Clinical Trials Data:The results of use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox Topical Solution, 8%, (Nail Lacquer), was applied for 48 weeks. At baseline, patients had 20-65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint \"complete cure\" (clear nail and negative mycology), and in two studies for the endpoint \"almost clear\" (≤10% nail involvement and negative mycology) at the end of study. These results are presented below. The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. *Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.",
"Description": "Ciclopirox Topical Solution, 8%, (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, 8%, (Nail Lacquer), contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8%, (Nail Lacquer), is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C 12H 17NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342- 05-0]. The chemical structure is:."
},
{
"NDCCode": "0713-0318-53",
"PackageDescription": "1 BOTTLE in 1 CARTON (0713-0318-53) > 60 mL in 1 BOTTLE",
"NDC11Code": "00713-0318-53",
"ProductNDC": "0713-0318",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078468",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110324",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.",
"Description": "Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water. The chemical name of calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5, 7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.6, and the following structural formula:."
},
{
"NDCCode": "0713-0326-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0326-15) > 15 g in 1 TUBE",
"NDC11Code": "00713-0326-15",
"ProductNDC": "0713-0326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19830324",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018642",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150827",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
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{
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}
]
}
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<StrengthUnit>kg/kg</StrengthUnit>
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<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>kg/kg</StrengthUnit>
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<LastUpdate>2017-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<SubstanceName>THEOPHYLLINE</SubstanceName>
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<ProprietaryName>Azithromycin</ProprietaryName>
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<LabelerName>REMEDYREPACK INC.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2022-09-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<ProductNDC>0713-0223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19880726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089526</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
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</NDC>
<NDC>
<NDCCode>0713-0223-60</NDCCode>
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<NDC11Code>00713-0223-60</NDC11Code>
<ProductNDC>0713-0223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19880726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089526</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880726</StartMarketingDatePackage>
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<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24H 30F 20 6, a molecular weight of 452.49 and the following structural formula:. Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (0713-0225-31) > 30 g in 1 TUBE</PackageDescription>
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<DosageFormName>CREAM</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089798</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089798</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-22</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (0713-0226-15) > 15 g in 1 TUBE</PackageDescription>
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<ProductNDC>0713-0226</ProductNDC>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>.25</StrengthNumber>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
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<ProductNDC>0713-0228</ProductNDC>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<StartMarketingDate>20150910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089796</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20150910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
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<NDC>
<NDCCode>0713-0229-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0229-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0229-15</NDC11Code>
<ProductNDC>0713-0229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089795</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
</NDC>
<NDC>
<NDCCode>0713-0229-80</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0229-80) / 80 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0229-80</NDC11Code>
<ProductNDC>0713-0229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089795</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
</NDC>
<NDC>
<NDCCode>0713-0317-88</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (0713-0317-88) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>00713-0317-88</NDC11Code>
<ProductNDC>0713-0317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070522</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078233</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070522</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.). Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be used only under medical supervision as described above. The effectiveness and safety of Ciclopirox Topical Solution, 8%,(Nail Lacquer), in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy,were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. The safety and efficacy of using Ciclopirox Topical Solution, 8%,(Nail Lacquer), daily for greater than 48 weeks have not been established. Clinical Trials Data:The results of use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox Topical Solution, 8%, (Nail Lacquer), was applied for 48 weeks. At baseline, patients had 20-65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint "complete cure" (clear nail and negative mycology), and in two studies for the endpoint "almost clear" (≤10% nail involvement and negative mycology) at the end of study. These results are presented below. The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. *Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.</IndicationAndUsage>
<Description>Ciclopirox Topical Solution, 8%, (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, 8%, (Nail Lacquer), contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8%, (Nail Lacquer), is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C 12H 17NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342- 05-0]. The chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0713-0318-53</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0713-0318-53) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00713-0318-53</NDC11Code>
<ProductNDC>0713-0318</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078468</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.</IndicationAndUsage>
<Description>Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water. The chemical name of calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5, 7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.6, and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0713-0326-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0326-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0326-15</NDC11Code>
<ProductNDC>0713-0326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830324</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018642</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin.</Description>
</NDC>
<NDC>
<NDCCode>0713-0326-37</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0326-37) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0326-37</NDC11Code>
<ProductNDC>0713-0326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830324</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018642</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin.</Description>
</NDC>
<NDC>
<NDCCode>0713-0327-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0327-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0327-15</NDC11Code>
<ProductNDC>0713-0327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070069</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin.</Description>
</NDC>
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