NDC 54766-829

Analpram HC

Hydrocortisone Acetate And Pramoxine Hydrochloride

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

Product ID54766-829_60626863-b3aa-b92b-e053-2991aa0a8f69
NDC54766-829
Product TypeHuman Prescription Drug
Proprietary NameAnalpram HC
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2015-08-05
Marketing CategoryANDA / ANDA
Application NumberANDA085979
Labeler NameSebela Pharmaceuticals Inc.
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54766-829-04

59 mL in 1 BOTTLE, PLASTIC (54766-829-04)
Marketing Start Date2015-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-829-04 [54766082904]

Analpram HC LOTION
Marketing CategoryANDA
Application NumberANDA085979
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-05

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE25 mg/mL

OpenFDA Data

SPL SET ID:1469733e-1723-4b8c-be33-ed8dfafd65e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1360956
  • 1234512
  • 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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