NDC 54766-729

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 ID54766-729_7d51ca9c-cb17-fbf6-e053-2a91aa0a0348
NDC54766-729
Product TypeHuman Prescription Drug
Proprietary NamePramosone
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2015-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA085980
Labeler NameSebela Pharmaceuticals Inc.
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54766-729-04

118 mL in 1 BOTTLE (54766-729-04)
Marketing Start Date2015-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-729-03 [54766072903]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085980
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-02
Marketing End Date2018-04-30

NDC 54766-729-06 [54766072906]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085980
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-02

NDC 54766-729-04 [54766072904]

Pramosone LOTION
Marketing CategoryANDA
Application NumberANDA085980
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-02

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:f207bdff-2f41-4eee-818e-198b6462863e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234393
  • 1234396

    • 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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