{
"NDC": [
{
"NDCCode": "45802-880-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-880-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0880-96",
"ProductNDC": "45802-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin, Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208479",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171127",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum."
},
{
"NDCCode": "45802-880-14",
"PackageDescription": "1 TUBE in 1 CARTON (45802-880-14) / 15 g in 1 TUBE",
"NDC11Code": "45802-0880-14",
"ProductNDC": "45802-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin, Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208479",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171127",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum."
},
{
"NDCCode": "45802-880-94",
"PackageDescription": "1 TUBE in 1 CARTON (45802-880-94) / 30 g in 1 TUBE",
"NDC11Code": "45802-0880-94",
"ProductNDC": "45802-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin, Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208479",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171127",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum."
},
{
"NDCCode": "45802-101-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-101-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0101-96",
"ProductNDC": "45802-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120313",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120313",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "45802-151-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-151-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0151-96",
"ProductNDC": "45802-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140114",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090256",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140114",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water."
},
{
"NDCCode": "45802-216-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-216-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0216-96",
"ProductNDC": "45802-216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120313",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120313",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "45802-244-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-244-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0244-96",
"ProductNDC": "45802-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207380",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171018",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Ointment for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "45802-308-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-308-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0308-96",
"ProductNDC": "45802-308",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoyl Peroxide",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120406",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160406",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "45802-496-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0496-96",
"ProductNDC": "45802-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077770",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150616",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "45802-706-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0706-96",
"ProductNDC": "45802-706",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tazarotene",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217075",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Tazarotene cream, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1).",
"Description": "Tazarotene Cream, 0.05% is for topical use and contains the active ingredient, tazarotene. Each gram of Tazarotene Cream, 0.05% contains 0.5 mg of tazarotene in a white cream base. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl) ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%; carbomer copolymer type B; carbomer homopolymer type B; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate."
},
{
"NDCCode": "45802-816-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0816-96",
"ProductNDC": "45802-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene, Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200174",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum."
},
{
"NDCCode": "45802-889-96",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-889-96) / 60 g in 1 BOTTLE",
"NDC11Code": "45802-0889-96",
"ProductNDC": "45802-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201009",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212367",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201009",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension."
},
{
"NDCCode": "45802-900-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-900-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0900-96",
"ProductNDC": "45802-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212104",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210120",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin Phosphate Gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin Phosphate Gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "45802-905-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-905-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0905-96",
"ProductNDC": "45802-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide",
"ProprietaryNameSuffix": "Aqueous Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080924",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-910-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-910-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0910-96",
"ProductNDC": "45802-910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Aqueous Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-915-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-915-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0915-96",
"ProductNDC": "45802-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Aqueous Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081204",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-921-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-921-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0921-96",
"ProductNDC": "45802-921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Hydroalcoholic Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-925-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0925-96",
"ProductNDC": "45802-925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075027",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080731",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Gel, 0.05% 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 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.",
"Description": "Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide."
},
{
"NDCCode": "45802-946-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-946-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0946-96",
"ProductNDC": "45802-946",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-20"
},
{
"NDCCode": "45802-954-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-954-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0954-96",
"ProductNDC": "45802-954",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Seb Prev",
"NonProprietaryName": "Sodium Sulfacetamide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-960-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-960-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0960-96",
"ProductNDC": "45802-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Seb Prev",
"NonProprietaryName": "Sodium Sulfacetamide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-966-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0966-96",
"ProductNDC": "45802-966",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063211",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080612",
"SamplePackage": "N",
"IndicationAndUsage": "Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.",
"Description": "Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose."
},
{
"NDCCode": "45802-989-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-989-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0989-96",
"ProductNDC": "45802-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021852",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .5",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Vitamin D [CS],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080601",
"SamplePackage": "N"
},
{
"NDCCode": "45802-995-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-995-96) > 60 g in 1 TUBE",
"NDC11Code": "45802-0995-96",
"ProductNDC": "45802-995",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Hydroalcoholic Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071004",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "70859-050-01",
"PackageDescription": "1 KIT in 1 KIT (70859-050-01) * 1 TUBE in 1 CARTON (45802-101-96) > 60 g in 1 TUBE * 1 TUBE in 1 CARTON (0299-4930-02) > 50 mL in 1 TUBE * 1 TUBE in 1 CARTON (0168-0202-30) > 30 g in 1 TUBE",
"NDC11Code": "70859-0050-01",
"ProductNDC": "70859-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucararxpak",
"NonProprietaryName": "Clindamycin Phosphate,benzoyl Peroxide,cetaphil",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000128",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190610",
"SamplePackage": "N",
"Description": "Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "68462-880-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68462-880-01) ",
"NDC11Code": "68462-0880-01",
"ProductNDC": "68462-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215995",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide."
},
{
"NDCCode": "68462-880-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-880-05) ",
"NDC11Code": "68462-0880-05",
"ProductNDC": "68462-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215995",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide."
},
{
"NDCCode": "68462-880-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68462-880-30) ",
"NDC11Code": "68462-0880-30",
"ProductNDC": "68462-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215995",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide."
},
{
"NDCCode": "45802-042-01",
"PackageDescription": "1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR",
"NDC11Code": "45802-0042-01",
"ProductNDC": "45802-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindesse",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20150703",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050793",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
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"SamplePackage": "N",
"IndicationAndUsage": "Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women (1.1).",
"Description": "Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans- 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(alpha)-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8PS. The structural formula is represented below. Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream."
},
{
"NDCCode": "45802-042-02",
"PackageDescription": "1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR",
"NDC11Code": "45802-0042-02",
"ProductNDC": "45802-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindesse",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20150703",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050793",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150703",
"SamplePackage": "Y",
"IndicationAndUsage": "Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women (1.1).",
"Description": "Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans- 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(alpha)-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8PS. The structural formula is represented below. Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream."
}
]
}
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<NDCList>
<NDC>
<NDCCode>45802-880-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-880-96) / 60 g in 1 TUBE</PackageDescription>
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<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
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<LastUpdate>2023-09-01</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (45802-880-14) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0880-14</NDC11Code>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<Description>Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum.</Description>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (45802-880-94) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0880-94</NDC11Code>
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<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. C47H75N017 MW = 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. C24H31F06 MW = 434.50. Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum.</Description>
</NDC>
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<PackageDescription>1 TUBE in 1 CARTON (45802-101-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0101-96</NDC11Code>
<ProductNDC>45802-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120313</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-151-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-151-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0151-96</NDC11Code>
<ProductNDC>45802-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140114</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090256</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140114</StartMarketingDatePackage>
<EndMarketingDatePackage>20250331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water.</Description>
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<ProductNDC>45802-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide</ProprietaryName>
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-244-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-244-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0244-96</NDC11Code>
<ProductNDC>45802-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
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<ApplicationNumber>ANDA207380</ApplicationNumber>
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<Status>Active</Status>
<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Ointment for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula. Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
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<NDCCode>45802-308-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-308-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0308-96</NDC11Code>
<ProductNDC>45802-308</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-496-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0496-96</NDC11Code>
<ProductNDC>45802-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077770</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>45802-706-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0706-96</NDC11Code>
<ProductNDC>45802-706</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tazarotene</ProprietaryName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217075</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tazarotene cream, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1).</IndicationAndUsage>
<Description>Tazarotene Cream, 0.05% is for topical use and contains the active ingredient, tazarotene. Each gram of Tazarotene Cream, 0.05% contains 0.5 mg of tazarotene in a white cream base. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl) ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%; carbomer copolymer type B; carbomer homopolymer type B; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>45802-816-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0816-96</NDC11Code>
<ProductNDC>45802-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene, Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200174</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-889-96</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-889-96) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0889-96</NDC11Code>
<ProductNDC>45802-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201009</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212367</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension.</Description>
</NDC>
<NDC>
<NDCCode>45802-900-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-900-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0900-96</NDC11Code>
<ProductNDC>45802-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212104</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin Phosphate Gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin Phosphate Gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>45802-905-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-905-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0905-96</NDC11Code>
<ProductNDC>45802-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Aqueous Base</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080924</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-910-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-910-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0910-96</NDC11Code>
<ProductNDC>45802-910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Aqueous Base</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-915-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-915-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0915-96</NDC11Code>
<ProductNDC>45802-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Aqueous Base</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-921-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-921-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0921-96</NDC11Code>
<ProductNDC>45802-921</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Hydroalcoholic Base</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-925-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0925-96</NDC11Code>
<ProductNDC>45802-925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075027</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</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>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Gel, 0.05% 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 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.</IndicationAndUsage>
<Description>Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>45802-946-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-946-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0946-96</NDC11Code>
<ProductNDC>45802-946</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-954-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-954-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0954-96</NDC11Code>
<ProductNDC>45802-954</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Seb Prev</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-960-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-960-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0960-96</NDC11Code>
<ProductNDC>45802-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Seb Prev</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-966-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0966-96</NDC11Code>
<ProductNDC>45802-966</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063211</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is C37H67NO13. It has the following structural formula. Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.</Description>
</NDC>
<NDC>
<NDCCode>45802-989-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-989-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0989-96</NDC11Code>
<ProductNDC>45802-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-995-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-995-96) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0995-96</NDC11Code>
<ProductNDC>45802-995</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Hydroalcoholic Base</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>70859-050-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70859-050-01) * 1 TUBE in 1 CARTON (45802-101-96) > 60 g in 1 TUBE * 1 TUBE in 1 CARTON (0299-4930-02) > 50 mL in 1 TUBE * 1 TUBE in 1 CARTON (0168-0202-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>70859-0050-01</NDC11Code>
<ProductNDC>70859-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucararxpak</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate,benzoyl Peroxide,cetaphil</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000128</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>68462-880-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68462-880-01) </PackageDescription>
<NDC11Code>68462-0880-01</NDC11Code>
<ProductNDC>68462-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215995</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-880-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-880-05) </PackageDescription>
<NDC11Code>68462-0880-05</NDC11Code>
<ProductNDC>68462-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215995</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-880-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68462-880-30) </PackageDescription>
<NDC11Code>68462-0880-30</NDC11Code>
<ProductNDC>68462-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215995</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>45802-042-01</NDCCode>
<PackageDescription>1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>45802-0042-01</NDC11Code>
<ProductNDC>45802-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindesse</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20150703</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050793</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women (1.1).</IndicationAndUsage>
<Description>Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans- 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(alpha)-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8PS. The structural formula is represented below. Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream.</Description>
</NDC>
<NDC>
<NDCCode>45802-042-02</NDCCode>
<PackageDescription>1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>45802-0042-02</NDC11Code>
<ProductNDC>45802-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindesse</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20150703</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050793</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150703</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women (1.1).</IndicationAndUsage>
<Description>Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans- 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(alpha)-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8PS. The structural formula is represented below. Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream.</Description>
</NDC>
</NDCList>