NDC 0713-0669

Hydrocortisone Valerate

Hydrocortisone Valerate

Hydrocortisone Valerate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Cosette Pharmaceuticals, Inc.. The primary component is Hydrocortisone Valerate.

Product ID0713-0669_cb58bae6-095d-441d-9dcf-f6d8975fd267
NDC0713-0669
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone Valerate
Generic NameHydrocortisone Valerate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date1998-08-25
Marketing CategoryANDA / ANDA
Application NumberANDA075043
Labeler NameCosette Pharmaceuticals, Inc.
Substance NameHYDROCORTISONE VALERATE
Active Ingredient Strength2 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0713-0669-15

1 TUBE in 1 CARTON (0713-0669-15) > 15 g in 1 TUBE
Marketing Start Date2016-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0669-37 [00713066937]

Hydrocortisone Valerate OINTMENT
Marketing CategoryANDA
Application NumberANDA075043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-01-19

NDC 0713-0669-15 [00713066915]

Hydrocortisone Valerate OINTMENT
Marketing CategoryANDA
Application NumberANDA075043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-01-19

NDC 0713-0669-60 [00713066960]

Hydrocortisone Valerate OINTMENT
Marketing CategoryANDA
Application NumberANDA075043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-01-19

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE VALERATE2 mg/g

OpenFDA Data

SPL SET ID:767df368-82fc-40ec-8faf-e6a3435c55b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370750
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Hydrocortisone Valerate" or generic name "Hydrocortisone Valerate"

    NDCBrand NameGeneric Name
    0713-0560Hydrocortisone ValerateHYDROCORTISONE VALERATE
    0713-0668Hydrocortisone ValerateHydrocortisone Valerate
    0713-0669Hydrocortisone ValerateHYDROCORTISONE VALERATE
    0713-0720HYDROCORTISONE VALERATEHYDROCORTISONE VALERATE
    21695-730Hydrocortisone ValerateHydrocortisone Valerate
    45802-455Hydrocortisone ValerateHydrocortisone Valerate
    50090-2525Hydrocortisone ValerateHydrocortisone Valerate
    51672-1290Hydrocortisone ValerateHydrocortisone Valerate
    51672-1292Hydrocortisone ValerateHydrocortisone Valerate
    61919-010HYDROCORTISONE VALERATEHYDROCORTISONE VALERATE
    68180-954HYDROCORTISONE VALERATEHYDROCORTISONE VALERATE
    68462-575Hydrocortisone valerateHydrocortisone valerate
    68462-836Hydrocortisone ValerateHYDROCORTISONE VALERATE

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