NDC 68682-392

HYDROCORTISONE BUTYRATE

Hydrocortisone Butyrate

HYDROCORTISONE BUTYRATE is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Oceanside Pharmaceuticals. The primary component is Hydrocortisone Butyrate.

Product ID68682-392_817313a6-6759-4700-9e82-e004034a9852
NDC68682-392
Product TypeHuman Prescription Drug
Proprietary NameHYDROCORTISONE BUTYRATE
Generic NameHydrocortisone Butyrate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-06-08
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022076
Labeler NameOceanside Pharmaceuticals
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68682-392-02

1 BOTTLE in 1 CARTON (68682-392-02) > 59 mL in 1 BOTTLE
Marketing Start Date2018-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-392-02 [68682039202]

HYDROCORTISONE BUTYRATE LOTION
Marketing CategoryNDA authorized generic
Application NumberNDA022076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-08

NDC 68682-392-04 [68682039204]

HYDROCORTISONE BUTYRATE LOTION
Marketing CategoryNDA authorized generic
Application NumberNDA022076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-08

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE BUTYRATE1 mg/mL

OpenFDA Data

SPL SET ID:dde66620-657b-4b30-bd30-4bb6e83612cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370763

    • Pharmacological Class

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

    NDC Crossover Matching brand name "HYDROCORTISONE BUTYRATE" or generic name "Hydrocortisone Butyrate"

    NDCBrand NameGeneric Name
    0472-0490Hydrocortisone ButyrateHydrocortisone Butyrate
    21695-971Hydrocortisone ButyrateHydrocortisone Butyrate
    51672-4061Hydrocortisone ButyrateHydrocortisone Butyrate
    51672-4074Hydrocortisone ButyrateHydrocortisone Butyrate
    51672-4083Hydrocortisone ButyrateHydrocortisone Butyrate
    51862-159HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
    52565-087Hydrocortisone ButyrateHYDROCORTISONE BUTYRATE
    68180-951Hydrocortisone ButyrateHydrocortisone Butyrate
    68462-464Hydrocortisone ButyrateHydrocortisone Butyrate
    68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
    68682-271Hydrocortisone Butyratehydrocortisone butyrate
    68682-273Hydrocortisone Butyratehydrocortisone butyrate
    68682-384Hydrocortisone ButyrateHYDROCORTISONE BUTYRATE
    68682-392HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE
    68788-7719Hydrocortisone ButyrateHydrocortisone Butyrate Lotion
    70512-032Hydrocortisone ButyrateHydrocortisone Butyrate
    16781-382LocoidHYDROCORTISONE BUTYRATE
    16781-391LocoidHYDROCORTISONE BUTYRATE
    16781-392LocoidHYDROCORTISONE BUTYRATE
    16781-384Locoid LipocreamHYDROCORTISONE BUTYRATE
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