NDC 54766-778

Analpram HC

Hydrocortisone Acetate And Pramoxine Hydrochloride

Analpram HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Hydrocortisone Acetate; Pramoxine Hydrochloride.

Product ID54766-778_6061fb5a-a9cb-1630-e053-2991aa0ac4d8
NDC54766-778
Product TypeHuman Prescription Drug
Proprietary NameAnalpram HC
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-08-05
Marketing CategoryANDA / ANDA
Application NumberANDA085368
Labeler NameSebela Pharmaceuticals Inc.
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength10 mg/g; mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54766-778-04

28.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04)
Marketing Start Date2015-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-778-04 [54766077804]

Analpram HC CREAM
Marketing CategoryANDA
Application NumberANDA085368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-08-05

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

OpenFDA Data

SPL SET ID:27b3c751-d972-4cb9-9235-55e29953bf8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1360954
  • 1235049
    • UPC Code
  • 0354766778049

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Analpram HC" or generic name "Hydrocortisone Acetate And Pramoxine Hydrochloride"

    NDCBrand NameGeneric Name
    54766-778Analpram HChydrocortisone acetate and pramoxine hydrochloride
    54766-799Analpram HChydrocortisone acetate and pramoxine hydrochloride
    54766-829Analpram HChydrocortisone acetate and pramoxine hydrochloride
    71399-2501hydrocortisone acetate and pramoxine hydrochloridehydrocortisone acetate and pramoxine hydrochloride
    69367-285Hydrocortisone Acetate Pramoxine HydrochlorideHydrocortisone Acetate and Pramoxine Hydrochloride
    73028-401Hydrocortisone Acetate Pramoxine HydrochlorideHydrocortisone Acetate and Pramoxine Hydrochloride
    79043-240Hydrocortisone Acetate Pramoxine HydrochlorideHYDROCORTISONE ACETATE and PRAMOXINE HYDROCHLORIDE
    69646-704Novacorthydrocortisone acetate and pramoxine hydrochloride
    49908-150PRAMCORTHYDROCORTISONE ACETATE and PRAMOXINE HYDROCHLORIDE
    54766-726Pramosonehydrocortisone acetate and pramoxine hydrochloride
    54766-729Pramosonehydrocortisone acetate and pramoxine hydrochloride
    54766-760Pramosonehydrocortisone acetate and pramoxine hydrochloride
    54766-763pramosonehydrocortisone acetate and pramoxine hydrochloride
    54766-777Pramosonehydrocortisone acetate and pramoxine hydrochloride
    54766-716Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride
    21695-982Proctofoamhydrocortisone acetate and pramoxine hydrochloride

    Trademark Results [Analpram HC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ANALPRAM HC
    ANALPRAM HC
    73659750 1476501 Live/Registered
    FERNDALE LABORATORIES, INC.
    1987-05-08
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