NDC 0378-8190

Clobetasol Propionate

Clobetasol Propionate

Clobetasol Propionate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Clobetasol Propionate.

Product ID0378-8190_90708776-a6e7-4e1f-89a7-da136ccf6113
NDC0378-8190
Product TypeHuman Prescription Drug
Proprietary NameClobetasol Propionate
Generic NameClobetasol Propionate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2017-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA075057
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCLOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8190-15

1 TUBE in 1 CARTON (0378-8190-15) > 15 g in 1 TUBE
Marketing Start Date2017-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8190-30 [00378819030]

Clobetasol Propionate OINTMENT
Marketing CategoryANDA
Application NumberANDA075057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-09-13

NDC 0378-8190-45 [00378819045]

Clobetasol Propionate OINTMENT
Marketing CategoryANDA
Application NumberANDA075057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-09-13

NDC 0378-8190-60 [00378819060]

Clobetasol Propionate OINTMENT
Marketing CategoryANDA
Application NumberANDA075057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-09-13

NDC 0378-8190-15 [00378819015]

Clobetasol Propionate OINTMENT
Marketing CategoryANDA
Application NumberANDA075057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-10-05

Drug Details

Active Ingredients

IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:8397251f-131f-4dcb-add1-7751993a66a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861448
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0168-0162Clobetasol Propionateclobetasol propionate
    0168-0163Clobetasol Propionateclobetasol propionate
    0168-0269Clobetasol PropionateClobetasol Propionate
    0168-0293Clobetasol Propionateclobetasol propionate
    0378-8055Clobetasol PropionateClobetasol Propionate
    0378-8167clobetasol propionateclobetasol propionate
    0378-8190Clobetasol PropionateClobetasol Propionate
    0472-0400Clobetasol PropionateClobetasol Propionate
    0472-0402Clobetasol PropionateClobetasol Propionate
    0472-0403Clobetasol PropionateClobetasol Propionate
    0472-0404Clobetasol PropionateClobetasol Propionate
    0574-2063Clobetasol PropionateCLOBETASOL PROPIONATE
    0574-2103Clobetasol PropionateClobetasol Propionate
    68071-4221Clobetasol PropionateClobetasol Propionate
    68071-4234Clobetasol PropionateClobetasol Propionate
    68071-4706Clobetasol PropionateClobetasol Propionate
    68071-4592Clobetasol PropionateClobetasol Propionate
    68180-551Clobetasol PropionateClobetasol Propionate
    68180-536Clobetasol PropionateClobetasol Propionate
    68180-956Clobetasol PropionateClobetasol Propionate
    68382-998clobetasol propionateclobetasol propionate
    68462-530Clobetasol PropionateClobetasol Propionate
    68462-480CLOBETASOL PROPIONATECLOBETASOL PROPIONATE
    68462-532CLOBETASOL PROPIONATECLOBETASOL PROPIONATE
    68462-608Clobetasol PropionateClobetasol Propionate
    68462-529Clobetasol PropionateClobetasol Propionate
    68788-0332Clobetasol PropionateClobetasol Propionate
    68788-7212Clobetasol PropionateClobetasol Propionate
    68788-9802Clobetasol PropionateClobetasol Propionate
    68788-9902Clobetasol PropionateClobetasol Propionate
    68788-9518Clobetasol PropionateClobetasol Propionate
    68788-9803Clobetasol PropionateClobetasol Propionate
    69238-1532Clobetasol PropionateClobetasol Propionate
    70030-166Clobetasol PropionateClobetasol Propionate
    70518-1178Clobetasol PropionateClobetasol Propionate
    0591-4039CLOBETASOL PROPIONATECLOBETASOL PROPIONATE
    70710-1456Clobetasol PropionateClobetasol Propionate
    70771-1209CLOBETASOL PROPIONATECLOBETASOL PROPIONATE
    70710-1401CLOBETASOL PROPIONATECLOBETASOL PROPIONATE
    70700-106Clobetasol PropionateClobetasol Propionate
    70700-109Clobetasol PropionateClobetasol Propionate
    70771-1080clobetasol propionateclobetasol propionate
    70771-1442Clobetasol PropionateClobetasol Propionate
    71085-007Clobetasol PropionateClobetasol Propionate
    71205-151Clobetasol PropionateClobetasol Propionate
    0713-0656Clobetasol PropionateClobetasol Propionate
    0781-7137clobetasol propionateclobetasol propionate
    16714-730Clobetasol PropionateClobetasol Propionate
    16714-782Clobetasol PropionateClobetasol Propionate
    21695-358Clobetasol PropionateClobetasol Propionate

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