NDC 0168-0016

HYDROCORTISONE

Hydrocortisone

HYDROCORTISONE is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Hydrocortisone.

Product ID0168-0016_293ecf1f-6b74-4484-a61f-57e5421c1729
NDC0168-0016
Product TypeHuman Otc Drug
Proprietary NameHYDROCORTISONE
Generic NameHydrocortisone
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date1981-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart348
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength5 mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0168-0016-31

1 TUBE in 1 CARTON (0168-0016-31) > 28 g in 1 TUBE
Marketing Start Date1981-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0016-31 [00168001631]

HYDROCORTISONE OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date1981-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE5 mg/g

OpenFDA Data

SPL SET ID:9f0a6c2d-82fc-4972-8b97-dd445a1f8e2e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310861
    • UPC Code
  • 0301680016313

    • 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
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