NDC 68180-951

Hydrocortisone Butyrate

Hydrocortisone Butyrate

Hydrocortisone Butyrate is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Hydrocortisone Butyrate.

Product ID68180-951_02b1142f-ced2-47db-8817-fa46d61176c6
NDC68180-951
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone Butyrate
Generic NameHydrocortisone Butyrate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA210209
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68180-951-01

1 BOTTLE in 1 CARTON (68180-951-01) > 59 mL in 1 BOTTLE
Marketing Start Date2018-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-951-02 [68180095102]

Hydrocortisone Butyrate LOTION
Marketing CategoryANDA
Application NumberANDA210209
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-17

NDC 68180-951-01 [68180095101]

Hydrocortisone Butyrate LOTION
Marketing CategoryANDA
Application NumberANDA210209
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-17

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE BUTYRATE1 mg/mL

OpenFDA Data

SPL SET ID:275f3fcf-1170-4df0-9a8d-1482bda409cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370763

    • 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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