NDC 51672-3009

U-Cort

Hydrocortisone Acetate

U-Cort is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Hydrocortisone Acetate.

Product ID51672-3009_367518ef-8e24-4823-8b29-78002f88aee7
NDC51672-3009
Product TypeHuman Prescription Drug
Proprietary NameU-Cort
Generic NameHydrocortisone Acetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1988-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA089472
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength10 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51672-3009-2

1 TUBE in 1 CARTON (51672-3009-2) > 28.35 g in 1 TUBE
Marketing Start Date1988-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-3009-8 [51672300908]

U-Cort CREAM
Marketing CategoryANDA
Application NumberANDA089472
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-06-13
Marketing End Date2012-03-06

NDC 51672-3009-2 [51672300902]

U-Cort CREAM
Marketing CategoryANDA
Application NumberANDA089472
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1988-06-13

NDC 51672-3009-4 [51672300904]

U-Cort CREAM
Marketing CategoryANDA
Application NumberANDA089472
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-06-13
Marketing End Date2012-03-06

NDC 51672-3009-5 [51672300905]

U-Cort CREAM
Marketing CategoryANDA
Application NumberANDA089472
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-06-13
Marketing End Date2012-03-06

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

OpenFDA Data

SPL SET ID:1eb217be-34f1-4b3b-a3a5-4dfb83fb6143
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043690
  • 1360949
  • Pharmacological Class

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

    NDC Crossover Matching brand name "U-Cort" or generic name "Hydrocortisone Acetate"

    NDCBrand NameGeneric Name
    51672-3009U-CortU-Cort
    0316-0140Ala ScalpHydrocortisone Acetate
    0713-0503ANUCORT-HCHydrocortisone Acetate
    43474-000bioCorneum HC Advanced Scar Supervision Anti-ItchHYDROCORTISONE ACETATE
    0037-6830Cortifoamhydrocortisone acetate
    16477-201Hemmorex-HChydrocortisone acetate
    16477-202Hemmorex-HChydrocortisone acetate
    0363-0972HydrocortisoneHydrocortisone Acetate
    11822-2069HydrocortisoneHydrocortisone Acetate
    0574-7090Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0574-7093Hydrocortisone AcetateHYDROCORTISONE ACETATE
    0713-0493Hydrocortisone AcetateHYDROCORTISONE ACETATE
    10135-751Hydrocortisone AcetateHydrocortisone Acetate
    16571-676Hydrocortisone AcetateHydrocortisone Acetate
    24689-102Hydrocortisone AcetateHydrocortisone Acetate
    24689-103Hydrocortisone AcetateHydrocortisone Acetate
    39328-029Hydrocortisone AcetateHydrocortisone Acetate
    39328-129Hydrocortisone AcetateHydrocortisone Acetate
    42494-301Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-302Hydrocortisone AcetateHYDROCORTISONE ACETATE
    42494-341Hydrocortisone AcetateHydrocortisone Acetate
    42494-342Hydrocortisone AcetateHydrocortisone Acetate
    47832-205Hydrocortisone AcetateHydrocortisone Acetate
    0179-8710KAISER PERMANENTEHydrocortisone acetate
    47682-923Medi-First 1% HydrocortisoneHydrocortisone acetate
    47682-207Medi-First Hydrocortisone 1%Hydrocortisone acetate
    15014-185NuCortHydrocortisone Acetate
    11509-5101Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHydrocortisone Acetate

    Trademark Results [U-Cort]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    U-CORT
    U-CORT
    87845779 not registered Live/Pending
    2R Investments, LLC
    2018-03-22
    U-CORT
    U-CORT
    78196480 2844754 Dead/Cancelled
    Taro Pharmaceuticals U.S.A., Inc.
    2002-12-19

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.