NDC 54766-835

MiCort HC

Hydrocortisone Acetate

MiCort HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Hydrocortisone Acetate.

Product ID54766-835_7cfef2a8-6e5c-48dc-e053-2991aa0a86db
NDC54766-835
Product TypeHuman Prescription Drug
Proprietary NameMiCort HC
Generic NameHydrocortisone Acetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA040396
Labeler NameSebela Pharmaceuticals Inc.
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54766-835-65

30 TUBE, WITH APPLICATOR in 1 CARTON (54766-835-65) > 4 g in 1 TUBE, WITH APPLICATOR (54766-835-02)
Marketing Start Date2016-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-835-98 [54766083598]

MiCort HC CREAM
Marketing CategoryANDA
Application NumberANDA040396
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13
Marketing End Date2020-05-31

NDC 54766-835-65 [54766083565]

MiCort HC CREAM
Marketing CategoryANDA
Application NumberANDA040396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-09-13
Marketing End Date2019-10-31

NDC 54766-835-04 [54766083504]

MiCort HC CREAM
Marketing CategoryANDA
Application NumberANDA040396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-09-13
Marketing End Date2020-04-30

NDC 54766-835-02 [54766083502]

MiCort HC CREAM
Marketing CategoryANDA
Application NumberANDA040396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-09-13
Marketing End Date2020-05-31

NDC 54766-835-90 [54766083590]

MiCort HC CREAM
Marketing CategoryANDA
Application NumberANDA040396
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE25 mg/g

OpenFDA Data

SPL SET ID:3c634bbe-cf9b-0db5-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1809845
  • 1809843
    • UPC Code
  • 0354766835049

    • Pharmacological Class

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

    NDC Crossover Matching brand name "MiCort HC" or generic name "Hydrocortisone Acetate"

    NDCBrand NameGeneric Name
    54766-835MiCort HCMiCort HC
    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
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