NDC 53113-262

Gadaderm Hydrocortisone

Hydrocortisone Acetate

Gadaderm Hydrocortisone is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Hydrocortisone Acetate.

Product ID53113-262_18d0cac1-584a-4679-8888-65051e73ebbd
NDC53113-262
Product TypeHuman Otc Drug
Proprietary NameGadaderm Hydrocortisone
Generic NameHydrocortisone Acetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameGadal Laboratories Inc
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength1 g/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53113-262-01

1 TUBE in 1 BOX (53113-262-01) > 42.52 g in 1 TUBE
Marketing Start Date2013-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53113-262-01 [53113026201]

Gadaderm Hydrocortisone CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE.5 g/100g

OpenFDA Data

SPL SET ID:986317c2-5f75-406a-ae13-375d11b21a44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1438754
  • 1250490

    • NDC Crossover Matching brand name "Gadaderm Hydrocortisone" or generic name "Hydrocortisone Acetate"

    NDCBrand NameGeneric Name
    53113-262Gadaderm HydrocortisoneGadaderm Hydrocortisone
    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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