{
"NDC": [
{
"NDCCode": "68462-466-99",
"PackageDescription": "18 POUCH in 1 CARTON (68462-466-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "68462-0466-99",
"ProductNDC": "68462-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201967",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121231",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use : 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. , 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. , 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets USP contain rizatriptan benzoate, USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 391.47 g/mol. Rizatriptan benzoate, USP is a white to off-white powder that is soluble in methanol; sparingly soluble in water; slightly soluble in acetone and ethanol. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: colloidal silicon dioxide, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch."
},
{
"NDCCode": "68462-466-72",
"PackageDescription": "12 POUCH in 1 CARTON (68462-466-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "68462-0466-72",
"ProductNDC": "68462-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201967",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121231",
"SamplePackage": "N"
},
{
"NDCCode": "65862-466-99",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-466-99) ",
"NDC11Code": "65862-0466-99",
"ProductNDC": "65862-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091114",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110321",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for:Immunocompetent Adult Patients (1.1): 1 Herpes labialis (cold sores)Treatment of recurrent episodes , 2 Genital herpesTreatment of recurrent episodesSuppressive therapy of recurrent episodes, 3 Herpes zoster (shingles) .",
"Description": "The active ingredient in famciclovir tablets, USP is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir is a white to pale yellow powder. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08.Famciclovir tablets, USP contain 125 mg, 250 mg, or 500 mg of famciclovir USP, together with the following inactive ingredients: anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "68462-465-99",
"PackageDescription": "18 POUCH in 1 CARTON (68462-465-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "68462-0465-99",
"ProductNDC": "68462-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201967",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121231",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use : 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. , 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. , 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate tablets USP contain rizatriptan benzoate, USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 391.47 g/mol. Rizatriptan benzoate, USP is a white to off-white powder that is soluble in methanol; sparingly soluble in water; slightly soluble in acetone and ethanol. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: colloidal silicon dioxide, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch."
},
{
"NDCCode": "68462-480-39",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLE",
"NDC11Code": "68462-0480-39",
"ProductNDC": "68462-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209004",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "68462-480-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-480-56) / 125 mL in 1 BOTTLE",
"NDC11Code": "68462-0480-56",
"ProductNDC": "68462-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209004",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "68462-529-17",
"PackageDescription": "1 TUBE in 1 CARTON (68462-529-17) / 15 g in 1 TUBE",
"NDC11Code": "68462-0529-17",
"ProductNDC": "68462-529",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209095",
"LabelerName": "Glenmark Pharmaceutcials Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180719",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax."
},
{
"NDCCode": "68462-529-35",
"PackageDescription": "1 TUBE in 1 CARTON (68462-529-35) / 30 g in 1 TUBE",
"NDC11Code": "68462-0529-35",
"ProductNDC": "68462-529",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209095",
"LabelerName": "Glenmark Pharmaceutcials Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180510",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax."
},
{
"NDCCode": "68462-529-47",
"PackageDescription": "1 TUBE in 1 CARTON (68462-529-47) / 45 g in 1 TUBE",
"NDC11Code": "68462-0529-47",
"ProductNDC": "68462-529",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209095",
"LabelerName": "Glenmark Pharmaceutcials Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180719",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax."
},
{
"NDCCode": "68462-529-65",
"PackageDescription": "1 TUBE in 1 CARTON (68462-529-65) / 60 g in 1 TUBE",
"NDC11Code": "68462-0529-65",
"ProductNDC": "68462-529",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209095",
"LabelerName": "Glenmark Pharmaceutcials Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180510",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax."
},
{
"NDCCode": "68462-530-17",
"PackageDescription": "1 TUBE in 1 CARTON (68462-530-17) / 15 g in 1 TUBE",
"NDC11Code": "68462-0530-17",
"ProductNDC": "68462-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208933",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "68462-530-35",
"PackageDescription": "1 TUBE in 1 CARTON (68462-530-35) / 30 g in 1 TUBE",
"NDC11Code": "68462-0530-35",
"ProductNDC": "68462-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208933",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "68462-530-47",
"PackageDescription": "1 TUBE in 1 CARTON (68462-530-47) / 45 g in 1 TUBE",
"NDC11Code": "68462-0530-47",
"ProductNDC": "68462-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208933",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "68462-530-65",
"PackageDescription": "1 TUBE in 1 CARTON (68462-530-65) / 60 g in 1 TUBE",
"NDC11Code": "68462-0530-65",
"ProductNDC": "68462-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208933",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "68462-532-28",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE",
"NDC11Code": "68462-0532-28",
"ProductNDC": "68462-532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210190",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180418",
"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 USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water."
},
{
"NDCCode": "68462-532-53",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLE",
"NDC11Code": "68462-0532-53",
"ProductNDC": "68462-532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210190",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180418",
"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 USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water."
},
{
"NDCCode": "68462-608-27",
"PackageDescription": "50 g in 1 CAN (68462-608-27) ",
"NDC11Code": "68462-0608-27",
"ProductNDC": "68462-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210809",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190216",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.",
"Description": "Clobetasol Propionate Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, a molecular weight of 466.97 g/mol. The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant."
},
{
"NDCCode": "68462-608-94",
"PackageDescription": "100 g in 1 CAN (68462-608-94) ",
"NDC11Code": "68462-0608-94",
"ProductNDC": "68462-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210809",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190216",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.",
"Description": "Clobetasol Propionate Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, a molecular weight of 466.97 g/mol. The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant."
},
{
"NDCCode": "42571-362-99",
"PackageDescription": "1 BOTTLE in 1 CARTON (42571-362-99) / 50 mL in 1 BOTTLE",
"NDC11Code": "42571-0362-99",
"ProductNDC": "42571-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211494",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191002",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate topical solution, USP 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 contains the active compound clobetasol propionate, USP 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, USP is (11β,16β)-21-chloro-9‑fluoro‑11‑hydroxy‑16‑methyl‑17‑(1‑oxo-propoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate, USP has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.97. It is a white to cream-colored crystalline powder, soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane. Sparingly soluble in ethanol; slightly soluble in benzene and diethyl ether; practically insoluble in water. Clobetasol propionate topical solution, USP contains clobetasol propionate, USP 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide."
},
{
"NDCCode": "68462-120-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (68462-120-05) ",
"NDC11Code": "68462-0120-05",
"ProductNDC": "68462-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216357",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221216",
"SamplePackage": "N",
"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-120-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (68462-120-90) ",
"NDC11Code": "68462-0120-90",
"ProductNDC": "68462-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216357",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221216",
"SamplePackage": "N",
"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-121-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (68462-121-05) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Nicardipine Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20221216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216357",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-121-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (68462-121-90) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
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"RouteName": "ORAL",
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"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
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"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "0168-0269-50",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (0168-0269-50) ",
"NDC11Code": "00168-0269-50",
"ProductNDC": "0168-0269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075391",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
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"IndicationAndUsage": "Clobetasol propionate topical solution USP, 0.05% 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 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution USP, 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide (for pH adjustment)."
},
{
"NDCCode": "0299-3847-00",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (0299-3847-00) / 15 mL in 1 BOTTLE (0299-3847-05) ",
"NDC11Code": "00299-3847-00",
"ProductNDC": "0299-3847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040301",
"EndMarketingDate": "20270101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021644",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20250831",
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"Description": "CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate."
},
{
"NDCCode": "0299-3847-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3847-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "00299-3847-04",
"ProductNDC": "0299-3847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040301",
"EndMarketingDate": "20270101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021644",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040301",
"EndMarketingDatePackage": "20270101",
"SamplePackage": "N",
"Description": "CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate."
},
{
"NDCCode": "0299-3848-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3848-02",
"ProductNDC": "0299-3848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021535",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water."
},
{
"NDCCode": "0299-3848-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "00299-3848-04",
"ProductNDC": "0299-3848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021535",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water."
},
{
"NDCCode": "0299-3849-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-01",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
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"StartMarketingDatePackage": "20051027",
"SamplePackage": "Y",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "0299-3849-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE",
"NDC11Code": "00299-3849-02",
"ProductNDC": "0299-3849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobex",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20051027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021835",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051027",
"SamplePackage": "N",
"Description": "CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
}
]
}
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<NDC>
<NDCCode>68462-466-99</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (68462-466-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0466-99</NDC11Code>
<ProductNDC>68462-466</ProductNDC>
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<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201967</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-12</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use : 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. , 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. , 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets USP contain rizatriptan benzoate, USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 391.47 g/mol. Rizatriptan benzoate, USP is a white to off-white powder that is soluble in methanol; sparingly soluble in water; slightly soluble in acetone and ethanol. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: colloidal silicon dioxide, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.</Description>
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<PackageDescription>12 POUCH in 1 CARTON (68462-466-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>68462-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201967</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-466-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (65862-466-99) </PackageDescription>
<NDC11Code>65862-0466-99</NDC11Code>
<ProductNDC>65862-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091114</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for:Immunocompetent Adult Patients (1.1): 1 Herpes labialis (cold sores)Treatment of recurrent episodes , 2 Genital herpesTreatment of recurrent episodesSuppressive therapy of recurrent episodes, 3 Herpes zoster (shingles) .</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets, USP is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir is a white to pale yellow powder. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08.Famciclovir tablets, USP contain 125 mg, 250 mg, or 500 mg of famciclovir USP, together with the following inactive ingredients: anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-465-99</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (68462-465-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0465-99</NDC11Code>
<ProductNDC>68462-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201967</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use : 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. , 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. , 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets USP contain rizatriptan benzoate, USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 391.47 g/mol. Rizatriptan benzoate, USP is a white to off-white powder that is soluble in methanol; sparingly soluble in water; slightly soluble in acetone and ethanol. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: colloidal silicon dioxide, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68462-480-39</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0480-39</NDC11Code>
<ProductNDC>68462-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209004</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>68462-480-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-480-56) / 125 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0480-56</NDC11Code>
<ProductNDC>68462-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209004</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>68462-529-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-529-17) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0529-17</NDC11Code>
<ProductNDC>68462-529</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209095</ApplicationNumber>
<LabelerName>Glenmark Pharmaceutcials Inc., USA</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>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-529-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-529-35) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0529-35</NDC11Code>
<ProductNDC>68462-529</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209095</ApplicationNumber>
<LabelerName>Glenmark Pharmaceutcials Inc., USA</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>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-529-47</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-529-47) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0529-47</NDC11Code>
<ProductNDC>68462-529</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209095</ApplicationNumber>
<LabelerName>Glenmark Pharmaceutcials Inc., USA</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>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-529-65</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-529-65) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0529-65</NDC11Code>
<ProductNDC>68462-529</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209095</ApplicationNumber>
<LabelerName>Glenmark Pharmaceutcials Inc., USA</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>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a 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/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 Cream USP, 0.05% contains the active compound clobetasol propionate, USP, 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, USP 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. Clobetasol propionate, USP has the molecular formula C25H32CIFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate and PEG 100 stearate, propylene glycol, purified water, sodium citrate anhydrous and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-530-17</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-530-17) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0530-17</NDC11Code>
<ProductNDC>68462-530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208933</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-530-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-530-35) / 30 g in 1 TUBE</PackageDescription>
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<ApplicationNumber>ANDA208933</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-530-47</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-530-47) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0530-47</NDC11Code>
<ProductNDC>68462-530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208933</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-530-65</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-530-65) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0530-65</NDC11Code>
<ProductNDC>68462-530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208933</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 grams 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 Ointment USP, 0.05% contains the active compound clobetasol propionate USP, 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 USP 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. Clobetasol propionate USP has the empirical formula of C25H32ClFO5 and a molecular weight of 466.97 g/mol. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-532-28</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0532-28</NDC11Code>
<ProductNDC>68462-532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210190</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</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 USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68462-532-53</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0532-53</NDC11Code>
<ProductNDC>68462-532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210190</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</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 USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68462-608-27</NDCCode>
<PackageDescription>50 g in 1 CAN (68462-608-27) </PackageDescription>
<NDC11Code>68462-0608-27</NDC11Code>
<ProductNDC>68462-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210809</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.</IndicationAndUsage>
<Description>Clobetasol Propionate Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, a molecular weight of 466.97 g/mol. The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
</NDC>
<NDC>
<NDCCode>68462-608-94</NDCCode>
<PackageDescription>100 g in 1 CAN (68462-608-94) </PackageDescription>
<NDC11Code>68462-0608-94</NDC11Code>
<ProductNDC>68462-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210809</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</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>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.</IndicationAndUsage>
<Description>Clobetasol Propionate Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, a molecular weight of 466.97 g/mol. The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
</NDC>
<NDC>
<NDCCode>42571-362-99</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42571-362-99) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>42571-0362-99</NDC11Code>
<ProductNDC>42571-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211494</ApplicationNumber>
<LabelerName>Micro Labs Limited</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>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution, USP 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 contains the active compound clobetasol propionate, USP 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, USP is (11β,16β)-21-chloro-9‑fluoro‑11‑hydroxy‑16‑methyl‑17‑(1‑oxo-propoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate, USP has the molecular formula C 25H 32ClFO 5and a molecular weight of 466.97. It is a white to cream-colored crystalline powder, soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane. Sparingly soluble in ethanol; slightly soluble in benzene and diethyl ether; practically insoluble in water. Clobetasol propionate topical solution, USP contains clobetasol propionate, USP 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-120-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (68462-120-05) </PackageDescription>
<NDC11Code>68462-0120-05</NDC11Code>
<ProductNDC>68462-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
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<NDC>
<NDCCode>68462-120-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (68462-120-90) </PackageDescription>
<NDC11Code>68462-0120-90</NDC11Code>
<ProductNDC>68462-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
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<NDC>
<NDCCode>68462-121-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (68462-121-05) </PackageDescription>
<NDC11Code>68462-0121-05</NDC11Code>
<ProductNDC>68462-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-121-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (68462-121-90) </PackageDescription>
<NDC11Code>68462-0121-90</NDC11Code>
<ProductNDC>68462-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0168-0269-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (0168-0269-50) </PackageDescription>
<NDC11Code>00168-0269-50</NDC11Code>
<ProductNDC>0168-0269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075391</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</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>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate topical solution USP, 0.05% 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 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution USP, 0.05% contains: 0.5 mg/g clobetasol propionate in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide (for pH adjustment).</Description>
</NDC>
<NDC>
<NDCCode>0299-3847-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (0299-3847-00) / 15 mL in 1 BOTTLE (0299-3847-05) </PackageDescription>
<NDC11Code>00299-3847-00</NDC11Code>
<ProductNDC>0299-3847</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<EndMarketingDate>20270101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021644</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040301</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.</Description>
</NDC>
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<NDCCode>0299-3847-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3847-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3847-04</NDC11Code>
<ProductNDC>0299-3847</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<EndMarketingDate>20270101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021644</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040301</StartMarketingDatePackage>
<EndMarketingDatePackage>20270101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0299-3848-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3848-02</NDC11Code>
<ProductNDC>0299-3848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021535</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0299-3848-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3848-04</NDC11Code>
<ProductNDC>0299-3848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021535</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLOBEX (clobetasol propionate) Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0299-3849-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3849-01) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3849-01</NDC11Code>
<ProductNDC>0299-3849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20051027</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021835</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051027</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>0299-3849-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00299-3849-02</NDC11Code>
<ProductNDC>0299-3849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobex</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20051027</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021835</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>CLOBEX ®(clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25H 32CIFO 5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX ®Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
</NDCList>