{
"NDC": [
{
"NDCCode": "68462-639-45",
"PackageDescription": "4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25) ",
"NDC11Code": "68462-0639-45",
"ProductNDC": "68462-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206391",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170919",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol."
},
{
"NDCCode": "84549-639-45",
"PackageDescription": "25 TABLET in 1 BOTTLE (84549-639-45) ",
"NDC11Code": "84549-0639-45",
"ProductNDC": "84549-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206391",
"LabelerName": "ProPharma Distribution",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol."
},
{
"NDCCode": "68462-639-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-639-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "68462-0639-01",
"ProductNDC": "68462-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206391",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170919",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol."
},
{
"NDCCode": "68462-146-45",
"PackageDescription": "4 BOTTLE in 1 BOX (68462-146-45) > 25 TABLET in 1 BOTTLE (68462-146-25)",
"NDC11Code": "68462-0146-45",
"ProductNDC": "68462-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050303",
"MarketingCategoryName": "UNAPPROVED OTHER",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-181-47",
"PackageDescription": "45 g in 1 TUBE (68462-181-47) ",
"NDC11Code": "68462-0181-47",
"ProductNDC": "68462-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090219",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100804",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.",
"Description": "Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "68462-181-48",
"PackageDescription": "2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE",
"NDC11Code": "68462-0181-48",
"ProductNDC": "68462-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090219",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100804",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.",
"Description": "Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "68462-192-55",
"PackageDescription": "45 g in 1 TUBE (68462-192-55) ",
"NDC11Code": "68462-0192-55",
"ProductNDC": "68462-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078541",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080528",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.43 and the following structural formula. Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax."
},
{
"NDCCode": "68462-225-55",
"PackageDescription": "45 g in 1 TUBE (68462-225-55) ",
"NDC11Code": "68462-0225-55",
"ProductNDC": "68462-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078571",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080528",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.43 and the following structural formula. Mometasone furoate, USP is a white or almost white powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, slightly soluble in alcohol. Each gram of mometasone furoate Ointment USP, 0.1% contains: 1 mg mometasone furoate, USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol monopalmitostearate, purified water, white petrolatum, and white wax."
},
{
"NDCCode": "68462-298-55",
"PackageDescription": "45 g in 1 TUBE (68462-298-55) ",
"NDC11Code": "68462-0298-55",
"ProductNDC": "68462-298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"NonProprietaryName": "Clotrimazole And Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202894",
"LabelerName": "Glenmark Pharmaceuticals Inc. USA",
"SubstanceName": "CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "10; .5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151106",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.",
"Description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84 g/mol, and the following structural formula. Clotrimazole, USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform and in alcohol. Betamethasone dipropionate, USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.60 g/mol, and the following structural formula. Betamethasone dipropionate, USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white, uniform and smooth cream consisting of benzyl alcohol, ceteareth-30, cetyl alcohol, mineral oil, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium hydroxide, stearyl alcohol, and white petrolatum."
},
{
"NDCCode": "68462-299-47",
"PackageDescription": "45 g in 1 TUBE (68462-299-47) ",
"NDC11Code": "68462-0299-47",
"ProductNDC": "68462-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alclometasone Dipropionate",
"NonProprietaryName": "Alclometasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079227",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ALCLOMETASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090730",
"SamplePackage": "N",
"IndicationAndUsage": "Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.",
"Description": "Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum."
},
{
"NDCCode": "68462-300-47",
"PackageDescription": "45 g in 1 TUBE (68462-300-47) ",
"NDC11Code": "68462-0300-47",
"ProductNDC": "68462-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alclometasone Dipropionate",
"NonProprietaryName": "Alclometasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079061",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ALCLOMETASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090623",
"SamplePackage": "N",
"IndicationAndUsage": "Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.",
"Description": "Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum."
},
{
"NDCCode": "68462-301-47",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "68462-0301-47",
"ProductNDC": "68462-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208108",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, and benzoyl peroxide, USP, 2.5%. Adapalene, USP a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid . It has the following structural formula. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.52 g/mol. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23 g/mol. Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide."
},
{
"NDCCode": "68462-301-55",
"PackageDescription": "45 g in 1 TUBE (68462-301-55) ",
"NDC11Code": "68462-0301-55",
"ProductNDC": "68462-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208108",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, and benzoyl peroxide, USP, 2.5%. Adapalene, USP a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid . It has the following structural formula. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.52 g/mol. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23 g/mol. Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide."
},
{
"NDCCode": "68462-403-55",
"PackageDescription": "45 g in 1 TUBE (68462-403-55) ",
"NDC11Code": "68462-0403-55",
"ProductNDC": "68462-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091314",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N"
},
{
"NDCCode": "68462-455-47",
"PackageDescription": "45 g in 1 TUBE (68462-455-47) ",
"NDC11Code": "68462-0455-47",
"ProductNDC": "68462-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091595",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120229",
"SamplePackage": "N",
"IndicationAndUsage": "Superficial Dermatophyte Infections. Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis. Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox USP. It is intended for topical dermatologic use only. Each gram of ciclopirox gel contains 7.70 mg of ciclopirox USP in a gel consisting of carbomer 940, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water. Ciclopirox gel is a white, slightly fluid gel. The chemical name for ciclopirox USP is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is."
},
{
"NDCCode": "68462-464-47",
"PackageDescription": "45 g in 1 CARTON (68462-464-47) ",
"NDC11Code": "68462-0464-47",
"ProductNDC": "68462-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202145",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum."
},
{
"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": "68462-530-47",
"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": "68462-575-47",
"PackageDescription": "45 g in 1 TUBE (68462-575-47) ",
"NDC11Code": "68462-0575-47",
"ProductNDC": "68462-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211129",
"LabelerName": "Glenamrk Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone Valerate Cream USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C26H38O6. It has the following structural formula. Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water.Each gram of Hydrocortisone Valerate Cream USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sepineo P 600, steareth-100, stearyl alcohol, sodium lauryl sulfate and white petrolatum."
},
{
"NDCCode": "68462-836-47",
"PackageDescription": "1 TUBE in 1 CARTON (68462-836-47) / 45 g in 1 TUBE",
"NDC11Code": "68462-0836-47",
"ProductNDC": "68462-836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211750",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"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": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate ointment, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone Valerate Ointment USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C26H38O6. It has the following structural formula:Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water.Each gram of Hydrocortisone Valerate Ointment, USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methyl paraben, mineral oil, polyoxyl stearyl ether, propylene glycol, sepineo P 600, steareth 100, stearyl alcohol, sodium lauryl sulfate, white petrolatum and purified water."
},
{
"NDCCode": "60760-639-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-639-60) ",
"NDC11Code": "60760-0639-60",
"ProductNDC": "60760-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202038",
"LabelerName": "St Mary's Medical Park Pharmacy",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220622",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3."
},
{
"NDCCode": "72611-639-25",
"PackageDescription": "25 VIAL in 1 CARTON (72611-639-25) > 4 mL in 1 VIAL (72611-639-01) ",
"NDC11Code": "72611-0639-25",
"ProductNDC": "72611-639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19721002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050441",
"LabelerName": "ALMAJECT, INC.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin phosphate products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin phosphate is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin phosphate and other antibacterial drugs, clindamycin phosphate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin Injection, USP in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34ClN208PS and the molecular weight is 504.96. The structural formula is represented below."
},
{
"NDCCode": "68462-421-21",
"PackageDescription": "210 mL in 1 BOTTLE (68462-421-21) ",
"NDC11Code": "68462-0421-21",
"ProductNDC": "68462-421",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atovaquone",
"NonProprietaryName": "Atovaquone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209685",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ATOVAQUONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antimalarial [EPC], Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171231",
"SamplePackage": "N",
"IndicationAndUsage": "Atovaquone oral suspension is a quinone antimicrobial drug indicated for: : 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2), 3 Limitations of Use (1.3):, 4 Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with atovaquone has not been studied., 5 The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.",
"Description": "Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans-2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum."
},
{
"NDCCode": "68462-421-69",
"PackageDescription": "42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH",
"NDC11Code": "68462-0421-69",
"ProductNDC": "68462-421",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atovaquone",
"NonProprietaryName": "Atovaquone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209685",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ATOVAQUONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antimalarial [EPC], Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171231",
"SamplePackage": "N",
"IndicationAndUsage": "Atovaquone oral suspension is a quinone antimicrobial drug indicated for: : 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2), 3 Limitations of Use (1.3):, 4 Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with atovaquone has not been studied., 5 The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.",
"Description": "Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans-2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum."
},
{
"NDCCode": "68462-609-35",
"PackageDescription": "1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBE",
"NDC11Code": "68462-0609-35",
"ProductNDC": "68462-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211769",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides."
},
{
"NDCCode": "68462-609-65",
"PackageDescription": "1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBE",
"NDC11Code": "68462-0609-65",
"ProductNDC": "68462-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211769",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
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"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides."
},
{
"NDCCode": "68462-609-94",
"PackageDescription": "1 TUBE in 1 CARTON (68462-609-94) / 100 g in 1 TUBE",
"NDC11Code": "68462-0609-94",
"ProductNDC": "68462-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211769",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides."
},
{
"NDCCode": "68462-659-27",
"PackageDescription": "12 CARTON in 1 BOX (68462-659-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "68462-0659-27",
"ProductNDC": "68462-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ryaltris",
"NonProprietaryName": "Olopatadine Hydrochloride And Mometasone Furoate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211746",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE",
"StrengthNumber": "665; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.",
"Description": "RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "68462-659-84",
"PackageDescription": "12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "68462-0659-84",
"ProductNDC": "68462-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ryaltris",
"NonProprietaryName": "Olopatadine Hydrochloride And Mometasone Furoate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211746",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE",
"StrengthNumber": "665; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-22",
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"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.",
"Description": "RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "68462-672-95",
"PackageDescription": "3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "68462-0672-95",
"ProductNDC": "68462-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203164",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150612",
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"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.45. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake. , 2 Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate."
}
]
}
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<PackageDescription>4 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25) </PackageDescription>
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<Description>Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol.</Description>
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<Description>Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09 g/mol.</Description>
</NDC>
<NDC>
<NDCCode>68462-146-45</NDCCode>
<PackageDescription>4 BOTTLE in 1 BOX (68462-146-45) > 25 TABLET in 1 BOTTLE (68462-146-25)</PackageDescription>
<NDC11Code>68462-0146-45</NDC11Code>
<ProductNDC>68462-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED OTHER</MarketingCategoryName>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>68462-181-47</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-181-47) </PackageDescription>
<NDC11Code>68462-0181-47</NDC11Code>
<ProductNDC>68462-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090219</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
<NDC>
<NDCCode>68462-181-48</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0181-48</NDC11Code>
<ProductNDC>68462-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090219</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
<NDC>
<NDCCode>68462-192-55</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-192-55) </PackageDescription>
<NDC11Code>68462-0192-55</NDC11Code>
<ProductNDC>68462-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078541</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], 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>20080528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.43 and the following structural formula. Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-225-55</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-225-55) </PackageDescription>
<NDC11Code>68462-0225-55</NDC11Code>
<ProductNDC>68462-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078571</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.43 and the following structural formula. Mometasone furoate, USP is a white or almost white powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, slightly soluble in alcohol. Each gram of mometasone furoate Ointment USP, 0.1% contains: 1 mg mometasone furoate, USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol monopalmitostearate, purified water, white petrolatum, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68462-298-55</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-298-55) </PackageDescription>
<NDC11Code>68462-0298-55</NDC11Code>
<ProductNDC>68462-298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Clotrimazole And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202894</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc. USA</LabelerName>
<SubstanceName>CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>10; .5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], 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>20151106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.</IndicationAndUsage>
<Description>Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84 g/mol, and the following structural formula. Clotrimazole, USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform and in alcohol. Betamethasone dipropionate, USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.60 g/mol, and the following structural formula. Betamethasone dipropionate, USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white, uniform and smooth cream consisting of benzyl alcohol, ceteareth-30, cetyl alcohol, mineral oil, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium hydroxide, stearyl alcohol, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-299-47</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-299-47) </PackageDescription>
<NDC11Code>68462-0299-47</NDC11Code>
<ProductNDC>68462-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alclometasone Dipropionate</ProprietaryName>
<NonProprietaryName>Alclometasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079227</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ALCLOMETASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.</IndicationAndUsage>
<Description>Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-300-47</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-300-47) </PackageDescription>
<NDC11Code>68462-0300-47</NDC11Code>
<ProductNDC>68462-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alclometasone Dipropionate</ProprietaryName>
<NonProprietaryName>Alclometasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079061</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ALCLOMETASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.</IndicationAndUsage>
<Description>Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate, USP is C28H37ClO7. It has the following structural formula:. Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-301-47</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68462-0301-47</NDC11Code>
<ProductNDC>68462-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208108</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, and benzoyl peroxide, USP, 2.5%. Adapalene, USP a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid . It has the following structural formula. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.52 g/mol. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23 g/mol. Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-301-55</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-301-55) </PackageDescription>
<NDC11Code>68462-0301-55</NDC11Code>
<ProductNDC>68462-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208108</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, and benzoyl peroxide, USP, 2.5%. Adapalene, USP a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid . It has the following structural formula. Adapalene, USP. Molecular formula: C28H28O3 Molecular weight: 412.52 g/mol. Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide, USP. Molecular formula: C14H10O4 Molecular weight: 242.23 g/mol. Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-403-55</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-403-55) </PackageDescription>
<NDC11Code>68462-0403-55</NDC11Code>
<ProductNDC>68462-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091314</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-455-47</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-455-47) </PackageDescription>
<NDC11Code>68462-0455-47</NDC11Code>
<ProductNDC>68462-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091595</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Superficial Dermatophyte Infections. Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis. Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox USP. It is intended for topical dermatologic use only. Each gram of ciclopirox gel contains 7.70 mg of ciclopirox USP in a gel consisting of carbomer 940, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water. Ciclopirox gel is a white, slightly fluid gel. The chemical name for ciclopirox USP is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>68462-464-47</NDCCode>
<PackageDescription>45 g in 1 CARTON (68462-464-47) </PackageDescription>
<NDC11Code>68462-0464-47</NDC11Code>
<ProductNDC>68462-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202145</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum.</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>68462-530-47</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>68462-575-47</NDCCode>
<PackageDescription>45 g in 1 TUBE (68462-575-47) </PackageDescription>
<NDC11Code>68462-0575-47</NDC11Code>
<ProductNDC>68462-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211129</ApplicationNumber>
<LabelerName>Glenamrk Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone Valerate Cream USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C26H38O6. It has the following structural formula. Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water.Each gram of Hydrocortisone Valerate Cream USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sepineo P 600, steareth-100, stearyl alcohol, sodium lauryl sulfate and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-836-47</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-836-47) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0836-47</NDC11Code>
<ProductNDC>68462-836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211750</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate ointment, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone Valerate Ointment USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C26H38O6. It has the following structural formula:Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water.Each gram of Hydrocortisone Valerate Ointment, USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methyl paraben, mineral oil, polyoxyl stearyl ether, propylene glycol, sepineo P 600, steareth 100, stearyl alcohol, sodium lauryl sulfate, white petrolatum and purified water.</Description>
</NDC>
<NDC>
<NDCCode>60760-639-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-639-60) </PackageDescription>
<NDC11Code>60760-0639-60</NDC11Code>
<ProductNDC>60760-639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202038</ApplicationNumber>
<LabelerName>St Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>72611-639-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (72611-639-25) > 4 mL in 1 VIAL (72611-639-01) </PackageDescription>
<NDC11Code>72611-0639-25</NDC11Code>
<ProductNDC>72611-639</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19721002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050441</ApplicationNumber>
<LabelerName>ALMAJECT, INC.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin phosphate products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin phosphate is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below. Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin phosphate and other antibacterial drugs, clindamycin phosphate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin Injection, USP in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is C18H34ClN208PS and the molecular weight is 504.96. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>68462-421-21</NDCCode>
<PackageDescription>210 mL in 1 BOTTLE (68462-421-21) </PackageDescription>
<NDC11Code>68462-0421-21</NDC11Code>
<ProductNDC>68462-421</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atovaquone</ProprietaryName>
<NonProprietaryName>Atovaquone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209685</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ATOVAQUONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atovaquone oral suspension is a quinone antimicrobial drug indicated for: : 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2), 3 Limitations of Use (1.3):, 4 Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with atovaquone has not been studied., 5 The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.</IndicationAndUsage>
<Description>Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans-2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>68462-421-69</NDCCode>
<PackageDescription>42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH</PackageDescription>
<NDC11Code>68462-0421-69</NDC11Code>
<ProductNDC>68462-421</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atovaquone</ProprietaryName>
<NonProprietaryName>Atovaquone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209685</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ATOVAQUONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atovaquone oral suspension is a quinone antimicrobial drug indicated for: : 1 Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1), 2 Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2), 3 Limitations of Use (1.3):, 4 Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with atovaquone has not been studied., 5 The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.</IndicationAndUsage>
<Description>Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans-2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>68462-609-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0609-35</NDC11Code>
<ProductNDC>68462-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211769</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides.</Description>
</NDC>
<NDC>
<NDCCode>68462-609-65</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0609-65</NDC11Code>
<ProductNDC>68462-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211769</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides.</Description>
</NDC>
<NDC>
<NDCCode>68462-609-94</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68462-609-94) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0609-94</NDC11Code>
<ProductNDC>68462-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211769</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides.</Description>
</NDC>
<NDC>
<NDCCode>68462-659-27</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (68462-659-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68462-0659-27</NDC11Code>
<ProductNDC>68462-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ryaltris</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride And Mometasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211746</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
<StrengthNumber>665; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.</IndicationAndUsage>
<Description>RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>68462-659-84</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68462-0659-84</NDC11Code>
<ProductNDC>68462-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ryaltris</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride And Mometasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211746</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
<StrengthNumber>665; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.</IndicationAndUsage>
<Description>RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>68462-672-95</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0672-95</NDC11Code>
<ProductNDC>68462-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203164</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.45. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake. , 2 Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate.</Description>
</NDC>
</NDCList>