NDC 16781-382

Locoid

Hydrocortisone Butyrate

Locoid is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Onset Dermatologics, Llc. The primary component is Hydrocortisone Butyrate.

Product ID16781-382_853a30a8-0bf5-4eb7-8e12-7636055e513b
NDC16781-382
Product TypeHuman Prescription Drug
Proprietary NameLocoid
Generic NameHydrocortisone Butyrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-07-03
Marketing CategoryNDA / NDA
Application NumberNDA018514
Labeler NameOnset Dermatologics, LLC
Substance NameHYDROCORTISONE BUTYRATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16781-382-15

1 TUBE in 1 CARTON (16781-382-15) > 15 g in 1 TUBE
Marketing Start Date2013-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16781-382-15 [16781038215]

Locoid CREAM
Marketing CategoryNDA
Application NumberNDA018514
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-07-03

NDC 16781-382-45 [16781038245]

Locoid CREAM
Marketing CategoryNDA
Application NumberNDA018514
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:c7b4f583-2f79-4242-8ed2-d0e19ce8a510
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370772
  • 1370770

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Locoid" or generic name "Hydrocortisone Butyrate"

    NDCBrand NameGeneric Name
    16781-382LocoidHYDROCORTISONE BUTYRATE
    16781-391LocoidHYDROCORTISONE BUTYRATE
    16781-392LocoidHYDROCORTISONE BUTYRATE
    82160-127Aquax-HHydrocortisone Butyrate
    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
    16781-384Locoid LipocreamHYDROCORTISONE BUTYRATE

    Trademark Results [Locoid]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOCOID
    LOCOID
    77570184 3602412 Live/Registered
    LEO PHARMA A/S
    2008-09-15
    LOCOID
    LOCOID
    73090740 1058915 Live/Registered
    GIST-BROCADES N.V.
    1976-06-17
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.