NDC 68682-384

Hydrocortisone Butyrate

Hydrocortisone Butyrate

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

Product ID68682-384_2deb3c7d-5da6-43fb-9032-2bcad50ebda5
NDC68682-384
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone Butyrate
Generic NameHydrocortisone Butyrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-07-03
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020769
Labeler NameOceanside Pharmaceuticals
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68682-384-45

1 TUBE in 1 CARTON (68682-384-45) > 45 g in 1 TUBE
Marketing Start Date2013-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-384-60 [68682038460]

Hydrocortisone Butyrate CREAM
Marketing CategoryNDA authorized generic
Application NumberNDA020769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-07-03

NDC 68682-384-45 [68682038445]

Hydrocortisone Butyrate CREAM
Marketing CategoryNDA authorized generic
Application NumberNDA020769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-07-03

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE BUTYRATE1 mg/g

OpenFDA Data

SPL SET ID:ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370770

    • Pharmacological Class

    • 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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