NDC 54766-726

Pramosone

Hydrocortisone Acetate And Pramoxine Hydrochloride

Pramosone 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 ID54766-726_606227a7-b310-1958-e053-2a91aa0a97f4
NDC54766-726
Product TypeHuman Prescription Drug
Proprietary NamePramosone
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2014-10-16
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 54766-726-04

118 mL in 1 BOTTLE, PLASTIC (54766-726-04)
Marketing Start Date2015-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-726-04 [54766072604]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085979
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-07

NDC 54766-726-75 [54766072675]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085979
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16

NDC 54766-726-06 [54766072606]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085979
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-07

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE25 mg/mL

OpenFDA Data

SPL SET ID:63606801-4fa8-11e4-916c-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234512
  • 1234514

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    54766-778Analpram 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
    54766-716Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride
    21695-982Proctofoamhydrocortisone acetate and pramoxine hydrochloride

    Trademark Results [Pramosone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRAMOSONE
    PRAMOSONE
    73390570 1270523 Live/Registered
    Ferndale Laboratories, Inc.
    1982-09-27
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