NDC 10337-162

Temovate

Clobetasol Propionate

Temovate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc.. The primary component is Clobetasol Propionate.

Product ID10337-162_87173868-9655-4128-9e5b-6b8dc657b1da
NDC10337-162
Product TypeHuman Prescription Drug
Proprietary NameTemovate
Generic NameClobetasol Propionate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date1996-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA074407
Labeler NamePharmaDerm a division of Fougera Pharmaceuticals Inc.
Substance NameCLOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10337-162-15

1 TUBE in 1 CARTON (10337-162-15) > 15 g in 1 TUBE
Marketing Start Date1996-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10337-162-15 [10337016215]

Temovate OINTMENT
Marketing CategoryANDA
Application NumberANDA074407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-02-23

NDC 10337-162-30 [10337016230]

Temovate OINTMENT
Marketing CategoryANDA
Application NumberANDA074407
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-02-23

Drug Details

Active Ingredients

IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:acecf5ab-dd5e-4046-ab47-b9ff415d4b2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861495
  • 861472
  • 861503
  • 861448
    • UPC Code
  • 0310337162303
  • 0310337163300

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0462-0269TemovateClobetasol Propionate
    0462-0293Temovateclobetasol propionate
    10337-163TemovateTemovate
    10337-162TemovateTemovate
    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
    0168-0301Clobetasol Propionate (emollient)clobetasol propionate
    0299-3847Clobexclobetasol propionate
    0299-3848ClobexClobetasol Propionate
    0299-3849CLOBEXclobetasol propionate
    0378-8182OLUXclobetasol propionate
    0378-8147OLUX-Eclobetasol propionate

    Trademark Results [Temovate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEMOVATE
    TEMOVATE
    73585431 1428974 Live/Registered
    GLAXO GROUP LIMITED
    1986-03-03
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