NDC 54766-716

Pramosone Cream

Hydrocortisone Acetate And Pramoxine Hydrochloride

Pramosone Cream 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 ID54766-716_6061fb5a-a9e6-1630-e053-2991aa0ac4d8
NDC54766-716
Product TypeHuman Prescription Drug
Proprietary NamePramosone Cream
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-08-04
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 54766-716-03

57 g in 1 TUBE (54766-716-03)
Marketing Start Date2015-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-716-03 [54766071603]

Pramosone Cream CREAM
Marketing CategoryANDA
Application NumberANDA085368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-08-04

NDC 54766-716-04 [54766071604]

Pramosone Cream CREAM
Marketing CategoryANDA
Application NumberANDA085368
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-08-04

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

OpenFDA Data

SPL SET ID:3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234519
  • 1116499
    • UPC Code
  • 0354766716034
  • 0354766716041

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Pramosone Cream" or generic name "Hydrocortisone Acetate And Pramoxine Hydrochloride"

    NDCBrand NameGeneric Name
    54766-716Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride
    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
    21695-982Proctofoamhydrocortisone acetate and pramoxine hydrochloride
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