NDC 0472-0490

Hydrocortisone Butyrate

Hydrocortisone Butyrate

Hydrocortisone Butyrate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Hydrocortisone Butyrate.

Product ID0472-0490_c3cbc815-c1ae-4e7c-8b4b-2ac3d5c3a005
NDC0472-0490
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone Butyrate
Generic NameHydrocortisone Butyrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-02-16
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA205134
Labeler NameActavis Pharma, Inc.
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0472-0490-60

1 TUBE in 1 CARTON (0472-0490-60) > 60 g in 1 TUBE
Marketing Start Date2018-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0472-0490-60 [00472049060]

Hydrocortisone Butyrate CREAM
Marketing CategoryANDA
Application NumberANDA205134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-02-16
Marketing End Date2019-08-31

NDC 0472-0490-45 [00472049045]

Hydrocortisone Butyrate CREAM
Marketing CategoryANDA
Application NumberANDA205134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-02-16
Marketing End Date2019-08-31

NDC 0472-0490-15 [00472049015]

Hydrocortisone Butyrate CREAM
Marketing CategoryANDA
Application NumberANDA205134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-16
Marketing End Date2018-02-16

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE BUTYRATE1 mg/g

OpenFDA Data

SPL SET ID:5e1a5aca-0d2d-475e-9f65-b8c8e8421391
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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