{
"NDC": [
{
"NDCCode": "51672-5330-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-5330-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-5330-03",
"ProductNDC": "51672-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Hydrocortisone Cream 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250326",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "51672-5330-1",
"PackageDescription": "1 TUBE in 1 CARTON (51672-5330-1) / 14.2 g in 1 TUBE",
"NDC11Code": "51672-5330-01",
"ProductNDC": "51672-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Hydrocortisone Cream 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250326",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "51672-5330-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-5330-2) / 28.4 g in 1 TUBE",
"NDC11Code": "51672-5330-02",
"ProductNDC": "51672-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Hydrocortisone Cream 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250326",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "11822-5330-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (11822-5330-3) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "11822-5330-03",
"ProductNDC": "11822-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Cough And Congestion Dm",
"NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Rite Aid",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "53002-5330-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-5330-3) ",
"NDC11Code": "53002-5330-03",
"ProductNDC": "53002-5330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200629",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. the relief of the signs and symptoms of. the management of.",
"Description": "Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as light blue color tablets containing 275 mg of naproxen sodium and dark blue color tablets containing 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. It has the following structural formula. Naproxen sodium USP is a white to creamy crystalline powder, freely soluble in water at neutral pH. Each naproxen sodium tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, PEG 8000, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "59116-5330-3",
"PackageDescription": "50 kg in 1 DRUM (59116-5330-3)",
"NDC11Code": "59116-5330-03",
"ProductNDC": "59116-5330",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ripretinib",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200224",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Cambrex Charles City, Inc",
"SubstanceName": "RIPRETINIB",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-04-28",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "62670-5330-3",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-5330-3) ",
"NDC11Code": "62670-5330-03",
"ProductNDC": "62670-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Bae Watch",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171129",
"EndMarketingDate": "20180529",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171129",
"EndMarketingDatePackage": "20180529",
"SamplePackage": "N"
},
{
"NDCCode": "67225-5330-3",
"PackageDescription": "1 POUCH in 1 BOX (67225-5330-3) / 1 CASE in 1 POUCH (67225-5330-2) / 4 g in 1 CASE (67225-5330-1) ",
"NDC11Code": "67225-5330-03",
"ProductNDC": "67225-5330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Age20s Signature Essence Pact Intense Cover Mini 15c",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aekyung Industrial Co., Ltd.",
"SubstanceName": "OCTOCRYLENE; TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": ".12; .2048; .26",
"StrengthUnit": "g/4g; g/4g; g/4g",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps prevent sunburn. ■ If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50090-5330-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5330-0) ",
"NDC11Code": "50090-5330-00",
"ProductNDC": "50090-5330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076274",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.",
"Description": "Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9 g/mol. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved \"APO\" on one side and \"CL 300\" on the other side. The tablets contain 392.0 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "51672-1253-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1253-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1253-03",
"ProductNDC": "51672-1253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019117",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840626",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1254-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1254-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1254-03",
"ProductNDC": "51672-1254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19890119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072494",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19890119",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1258-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1258-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1258-03",
"ProductNDC": "51672-1258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074249",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960708",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "51672-1259-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1259-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1259-03",
"ProductNDC": "51672-1259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074248",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960712",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "51672-1260-3",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "51672-1260-03",
"ProductNDC": "51672-1260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074580",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960729",
"SamplePackage": "N",
"IndicationAndUsage": "Prescription CLOTRIMAZOLE TOPICAL SOLUTION product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis.",
"Description": "CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula. MOLECULAR FORMULA C 22H 17CIN 2 MOLECULAR WEIGHT 344.85. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400."
},
{
"NDCCode": "51672-1261-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1261-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1261-03",
"ProductNDC": "51672-1261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074904",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980714",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1262-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1262-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1262-03",
"ProductNDC": "51672-1262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074286",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960607",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1263-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1263-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1263-03",
"ProductNDC": "51672-1263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19871222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062364",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19871222",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "51672-1264-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1264-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1264-03",
"ProductNDC": "51672-1264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075008",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19990630",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1270-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1270-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1270-03",
"ProductNDC": "51672-1270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073193",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901130",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1271-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1271-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1271-03",
"ProductNDC": "51672-1271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073210",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19901130",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "51672-1271-8",
"PackageDescription": "3 TUBE in 1 CARTON (51672-1271-8) > 100 g in 1 TUBE",
"NDC11Code": "51672-1271-08",
"ProductNDC": "51672-1271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19901130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073210",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "51672-1272-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1272-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1272-03",
"ProductNDC": "51672-1272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063305",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930329",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "51672-1279-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1279-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1279-03",
"ProductNDC": "51672-1279",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19970729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074935",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970729",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution."
},
{
"NDCCode": "51672-1280-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1280-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1280-03",
"ProductNDC": "51672-1280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19920630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073548",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19920630",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide cream, 0.05% and desonide ointment, 0.05% are low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Cream, 0.05% and Desonide Ointment, 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α-)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Cream, 0.05% and Desonide Ointment, 0.05%, is C 24H 32O 6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Cream, 0.05% contains 0.5 milligram of desonide in a compatible vehicle buffered to the pH range of normal skin. It contains aluminum acetate basic, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, glycerin, mineral oil, purified water, white petrolatum and white wax. It is preserved with methylparaben. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide in an ointment base consisting of mineral oil and white petrolatum. It is a smooth, uniform petrolatum-type ointment."
},
{
"NDCCode": "51672-1281-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1281-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1281-03",
"ProductNDC": "51672-1281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19940803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074254",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19940803",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide cream, 0.05% and desonide ointment, 0.05% are low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Cream, 0.05% and Desonide Ointment, 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α-)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Cream, 0.05% and Desonide Ointment, 0.05%, is C 24H 32O 6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Cream, 0.05% contains 0.5 milligram of desonide in a compatible vehicle buffered to the pH range of normal skin. It contains aluminum acetate basic, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, glycerin, mineral oil, purified water, white petrolatum and white wax. It is preserved with methylparaben. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide in an ointment base consisting of mineral oil and white petrolatum. It is a smooth, uniform petrolatum-type ointment."
},
{
"NDCCode": "51672-1290-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1290-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1290-03",
"ProductNDC": "51672-1290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075042",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980825",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum."
},
{
"NDCCode": "51672-1292-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1292-03",
"ProductNDC": "51672-1292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075043",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980825",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum."
},
{
"NDCCode": "51672-1293-3",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-3) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "51672-1293-03",
"ProductNDC": "51672-1293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075224",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981116",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
"Description": "Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione and it has the following structural formula. Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base composed of carbomer 934P, isopropyl alcohol (39.3%), purified water, and sodium hydroxide."
},
{
"NDCCode": "51672-1294-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1294-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1294-03",
"ProductNDC": "51672-1294",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075279",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990528",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "51672-1295-3",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1295-3) / 60 g in 1 TUBE",
"NDC11Code": "51672-1295-03",
"ProductNDC": "51672-1295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diflorasone Diacetate",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075331",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19990514",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below. Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of glyceryl monostearate, propylene glycol and white petrolatum."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51672-5330-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-5330-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-5330-03</NDC11Code>
<ProductNDC>51672-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocortisone Cream 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51672-5330-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-5330-1) / 14.2 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-5330-01</NDC11Code>
<ProductNDC>51672-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocortisone Cream 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51672-5330-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-5330-2) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-5330-02</NDC11Code>
<ProductNDC>51672-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocortisone Cream 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryseborrheic dermatitispsoriasis. temporarily relieves external anal and genital itching. other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-5330-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (11822-5330-3) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-5330-03</NDC11Code>
<ProductNDC>11822-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Cough And Congestion Dm</ProprietaryName>
<NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051231</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>53002-5330-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-5330-3) </PackageDescription>
<NDC11Code>53002-5330-03</NDC11Code>
<ProductNDC>53002-5330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200629</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. the relief of the signs and symptoms of. the management of.</IndicationAndUsage>
<Description>Naproxen sodium tablets, USP are nonsteroidal anti-inflammatory drugs and available as light blue color tablets containing 275 mg of naproxen sodium and dark blue color tablets containing 550 mg of naproxen sodium for oral administration. Naproxen sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. It has the following structural formula. Naproxen sodium USP is a white to creamy crystalline powder, freely soluble in water at neutral pH. Each naproxen sodium tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, PEG 8000, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59116-5330-3</NDCCode>
<PackageDescription>50 kg in 1 DRUM (59116-5330-3)</PackageDescription>
<NDC11Code>59116-5330-03</NDC11Code>
<ProductNDC>59116-5330</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ripretinib</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200224</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cambrex Charles City, Inc</LabelerName>
<SubstanceName>RIPRETINIB</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-04-28</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62670-5330-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-5330-3) </PackageDescription>
<NDC11Code>62670-5330-03</NDC11Code>
<ProductNDC>62670-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Bae Watch</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171129</StartMarketingDate>
<EndMarketingDate>20180529</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171129</StartMarketingDatePackage>
<EndMarketingDatePackage>20180529</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67225-5330-3</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (67225-5330-3) / 1 CASE in 1 POUCH (67225-5330-2) / 4 g in 1 CASE (67225-5330-1) </PackageDescription>
<NDC11Code>67225-5330-03</NDC11Code>
<ProductNDC>67225-5330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Age20s Signature Essence Pact Intense Cover Mini 15c</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aekyung Industrial Co., Ltd.</LabelerName>
<SubstanceName>OCTOCRYLENE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.12; .2048; .26</StrengthNumber>
<StrengthUnit>g/4g; g/4g; g/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps prevent sunburn. ■ If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-5330-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-5330-0) </PackageDescription>
<NDC11Code>50090-5330-00</NDC11Code>
<ProductNDC>50090-5330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076274</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.</IndicationAndUsage>
<Description>Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9 g/mol. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved "APO" on one side and "CL 300" on the other side. The tablets contain 392.0 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51672-1253-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1253-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1253-03</NDC11Code>
<ProductNDC>51672-1253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019117</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1254-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1254-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1254-03</NDC11Code>
<ProductNDC>51672-1254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19890119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072494</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1258-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1258-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1258-03</NDC11Code>
<ProductNDC>51672-1258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074249</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1259-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1259-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1259-03</NDC11Code>
<ProductNDC>51672-1259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074248</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1260-3</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51672-1260-03</NDC11Code>
<ProductNDC>51672-1260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074580</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prescription CLOTRIMAZOLE TOPICAL SOLUTION product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis.</IndicationAndUsage>
<Description>CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula. MOLECULAR FORMULA C 22H 17CIN 2 MOLECULAR WEIGHT 344.85. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400.</Description>
</NDC>
<NDC>
<NDCCode>51672-1261-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1261-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1261-03</NDC11Code>
<ProductNDC>51672-1261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074904</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1262-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1262-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1262-03</NDC11Code>
<ProductNDC>51672-1262</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074286</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1263-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1263-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1263-03</NDC11Code>
<ProductNDC>51672-1263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19871222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062364</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19871222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1264-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1264-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1264-03</NDC11Code>
<ProductNDC>51672-1264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075008</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1270-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1270-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1270-03</NDC11Code>
<ProductNDC>51672-1270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073193</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1271-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1271-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1271-03</NDC11Code>
<ProductNDC>51672-1271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073210</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. Each gram of desoximetasone gel USP, 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C 22H 29FO 4and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51672-1271-8</NDCCode>
<PackageDescription>3 TUBE in 1 CARTON (51672-1271-8) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1271-08</NDC11Code>
<ProductNDC>51672-1271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19901130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073210</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>51672-1272-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1272-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1272-03</NDC11Code>
<ProductNDC>51672-1272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063305</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream and Ointment for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate, polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben, propylparaben and sorbitol. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1279-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1279-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1279-03</NDC11Code>
<ProductNDC>51672-1279</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19970729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074935</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. Fluocinonide Cream USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum. Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>51672-1280-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1280-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1280-03</NDC11Code>
<ProductNDC>51672-1280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19920630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073548</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide cream, 0.05% and desonide ointment, 0.05% are low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Cream, 0.05% and Desonide Ointment, 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α-)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Cream, 0.05% and Desonide Ointment, 0.05%, is C 24H 32O 6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Cream, 0.05% contains 0.5 milligram of desonide in a compatible vehicle buffered to the pH range of normal skin. It contains aluminum acetate basic, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, glycerin, mineral oil, purified water, white petrolatum and white wax. It is preserved with methylparaben. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide in an ointment base consisting of mineral oil and white petrolatum. It is a smooth, uniform petrolatum-type ointment.</Description>
</NDC>
<NDC>
<NDCCode>51672-1281-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1281-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1281-03</NDC11Code>
<ProductNDC>51672-1281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19940803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074254</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide cream, 0.05% and desonide ointment, 0.05% are low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Cream, 0.05% and Desonide Ointment, 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α-)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Cream, 0.05% and Desonide Ointment, 0.05%, is C 24H 32O 6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Cream, 0.05% contains 0.5 milligram of desonide in a compatible vehicle buffered to the pH range of normal skin. It contains aluminum acetate basic, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, glycerin, mineral oil, purified water, white petrolatum and white wax. It is preserved with methylparaben. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide in an ointment base consisting of mineral oil and white petrolatum. It is a smooth, uniform petrolatum-type ointment.</Description>
</NDC>
<NDC>
<NDCCode>51672-1290-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1290-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1290-03</NDC11Code>
<ProductNDC>51672-1290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075042</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1292-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1292-03</NDC11Code>
<ProductNDC>51672-1292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075043</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1293-3</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-3) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51672-1293-03</NDC11Code>
<ProductNDC>51672-1293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075224</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
<Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione and it has the following structural formula. Clobetasol propionate has the molecular formula C 25H 32ClFO 5and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base composed of carbomer 934P, isopropyl alcohol (39.3%), purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51672-1294-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1294-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1294-03</NDC11Code>
<ProductNDC>51672-1294</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075279</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of carbomer 934P, propylene glycol, purified water, and sodium hydroxide. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, stearyl alcohol, and white wax. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1295-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1295-3) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1295-03</NDC11Code>
<ProductNDC>51672-1295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diflorasone Diacetate</ProprietaryName>
<NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075331</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below. Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of glyceryl monostearate, propylene glycol and white petrolatum.</Description>
</NDC>
</NDCList>