NDC 50382-010

Hydrocortisone

Hydrocortisone

Hydrocortisone is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Priva Te Limited. The primary component is Hydrocortisone Acetate.

Product ID50382-010_a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38
NDC50382-010
Product TypeHuman Otc Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-08-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameGalentic Pharma (India) Priva Te Limited
Substance NameHYDROCORTISONE ACETATE
Active Ingredient Strength1 g/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 50382-010-02

425 g in 1 JAR (50382-010-02)
Marketing Start Date2013-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50382-010-01 [50382001001]

Hydrocortisone CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-07
Inactivation Date2019-11-27

NDC 50382-010-02 [50382001002]

Hydrocortisone CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-07
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE1 g/100g

OpenFDA Data

SPL SET ID:eb49a81d-35d8-415c-a6a4-111eeb7125fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043690
  • NDC Crossover Matching brand name "Hydrocortisone" or generic name "Hydrocortisone"

    NDCBrand NameGeneric Name
    0115-1696HYDROCORTISONEhydrocortisone
    0115-1697HYDROCORTISONEhydrocortisone
    0115-1700HYDROCORTISONEhydrocortisone
    0143-1252HydrocortisoneHydrocortisone
    0143-1253HydrocortisoneHydrocortisone
    0143-1254HydrocortisoneHydrocortisone
    0168-0014HYDROCORTISONEHYDROCORTISONE
    0168-0015hydrocortisoneHydrocortisone
    0168-0016HYDROCORTISONEHYDROCORTISONE
    0168-0020HydrocortisoneHydrocortisone
    0168-0080HydrocortisoneHydrocortisone
    0168-0146HydrocortisoneHydrocortisone
    0168-0154HYDROCORTISONEHYDROCORTISONE
    0168-0181HYDROCORTISONEHYDROCORTISONE
    0168-0288Hydrocortisonehydrocortisone
    67777-004HydrocortisoneHydrocortisone
    67777-224HydrocortisoneHydrocortisone
    67777-237HydrocortisoneHydrocortisone
    67777-415HydrocortisoneHydrocortisone
    67777-003HydrocortisoneHydrocortisone
    67777-417HydrocortisoneHydrocortisone
    68071-1844HYDROCORTISONEHYDROCORTISONE
    68071-1581HydrocortisoneHydrocortisone
    68071-4511HydrocortisoneHydrocortisone
    68071-4582HydrocortisoneHydrocortisone
    68084-789HydrocortisoneHydrocortisone
    68084-469HydrocortisoneHydrocortisone
    68151-4021HydrocortisoneHydrocortisone
    68151-2269HYDROCORTISONEHYDROCORTISONE
    68084-930HydrocortisoneHydrocortisone
    0472-0321HydrocortisoneHydrocortisone
    0472-0337HydrocortisoneHydrocortisone
    0498-0800HYDROCORTISONEHYDROCORTISONE
    68599-1182HydrocortisoneHydrocortisone
    68786-223HydrocortisoneHydrocortisone
    68786-224HydrocortisoneHydrocortisone
    68788-0645hydrocortisonehydrocortisone
    68788-9922HydrocortisoneHydrocortisone
    68788-9715HydrocortisoneHydrocortisone
    68788-9856HydrocortisoneHydrocortisone
    69396-003HydrocortisoneHydrocortisone
    69842-627hydrocortisonehydrocortisone
    70518-0143HydrocortisoneHydrocortisone
    70518-1360HydrocortisoneHydrocortisone
    0603-0535HydrocortisoneHydrocortisone
    0603-3901HydrocortisoneHydrocortisone
    0603-3900HydrocortisoneHydrocortisone
    0603-7781HydrocortisoneHydrocortisone
    0603-3899HydrocortisoneHydrocortisone
    71335-0812HydrocortisoneHydrocortisone

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