NDC 0168-0355

Halobetasol Propionate

Halobetasol Propionate

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

Product ID0168-0355_13b31048-e881-404d-8321-ee882fc4456c
NDC0168-0355
Product TypeHuman Prescription Drug
Proprietary NameHalobetasol Propionate
Generic NameHalobetasol Propionate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2004-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA077001
Labeler NameFougera Pharmaceuticals Inc.
Substance NameHALOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0168-0355-15

15 g in 1 TUBE (0168-0355-15)
Marketing Start Date2004-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0355-15 [00168035515]

Halobetasol Propionate CREAM
Marketing CategoryANDA
Application NumberANDA077001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-12-16

NDC 0168-0355-50 [00168035550]

Halobetasol Propionate CREAM
Marketing CategoryANDA
Application NumberANDA077001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-12-16

Drug Details

Active Ingredients

IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:511a33bb-3f21-4ee6-b63c-dc616047329f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977990
    • UPC Code
  • 0301680355153

    • Pharmacological Class

    • 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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