NDC 0713-0758

Halobetasol Propionate

Halobetasol Propionate

Halobetasol Propionate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Cosette Pharmaceuticals, Inc.. The primary component is Halobetasol Propionate.

Product ID0713-0758_77070f42-00a6-40d4-90a0-4fb679550b86
NDC0713-0758
Product TypeHuman Prescription Drug
Proprietary NameHalobetasol Propionate
Generic NameHalobetasol Propionate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA077109
Labeler NameCosette Pharmaceuticals, Inc.
Substance NameHALOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0713-0758-15

1 TUBE in 1 CARTON (0713-0758-15) > 15 g in 1 TUBE
Marketing Start Date2019-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0758-86 [00713075886]

Halobetasol Propionate CREAM
Marketing CategoryANDA
Application NumberANDA077109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-21

NDC 0713-0758-15 [00713075815]

Halobetasol Propionate CREAM
Marketing CategoryANDA
Application NumberANDA077109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-21

Drug Details

Active Ingredients

IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:bb8bd845-6ec9-4df6-a54e-8d7c5e95b66d
Manufacturer
UNII
UPC Code
  • 0307130758154
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Halobetasol Propionate" or generic name "Halobetasol Propionate"

    NDCBrand NameGeneric Name
    0168-0355Halobetasol Propionatehalobetasol propionate
    0168-0356Halobetasol Propionatehalobetasol propionate
    0713-0339Halobetasol PropionateHalobetasol Propionate
    0713-0639Halobetasol PropionateHalobetasol Propionate
    0713-0640Halobetasol PropionateHalobetasol Propionate
    0713-0758Halobetasol PropionateHalobetasol Propionate
    42254-250Halobetasol PropionateHalobetasol Propionate
    45802-129Halobetasol PropionateHalobetasol Propionate
    45802-131Halobetasol PropionateHalobetasol Propionate
    51672-1321Halobetasol PropionateHalobetasol Propionate
    51672-1322Halobetasol PropionateHalobetasol Propionate
    51862-606Halobetasol propionateHalobetasol propionate
    52565-073Halobetasol Propionatehalobetasol propionate
    52959-961Halobetasol PropionateHalobetasol Propionate
    55337-606Halobetasol propionateHalobetasol propionate
    63629-8664Halobetasol PropionateHalobetasol Propionate
    70512-033Halobetasol PropionateHalobetasol Propionate
    63739-998Halobetasol PropionateHalobetasol Propionate
    70752-119Halobetasol PropionateHalobetasol Propionate
    0187-0002Bryhalihalobetasol propionate
    51862-604LEXETTEHalobetasol propionate
    10631-102Ultravatehalobetasol propionate
    10631-103Ultravatehalobetasol propionate
    10631-122Ultravatehalobetasol propionate
    10631-119Ultravate XHalobetasol Propionate
    10631-121Ultravate XHalobetasol Propionate

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