NDC 69646-704

Novacort

Hydrocortisone Acetate And Pramoxine Hydrochloride

Novacort is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Novum Pharma, Llc. The primary component is Hydrocortisone Acetate; Pramoxine Hydrochloride.

Product ID69646-704_8d6b43c3-0372-42e2-9f9d-c4b82a8c2203
NDC69646-704
Product TypeHuman Prescription Drug
Proprietary NameNovacort
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2015-03-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameNovum Pharma, LLC
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength20 mg/g; mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69646-704-01

1 g in 1 PACKET (69646-704-01)
Marketing Start Date2015-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69646-704-01 [69646070401]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-01

NDC 69646-704-03 [69646070403]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16

NDC 69646-704-11 [69646070411]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16

NDC 69646-704-02 [69646070402]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-01

NDC 69646-704-38 [69646070438]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-01

NDC 69646-704-26 [69646070426]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-03-01

NDC 69646-704-08 [69646070408]

Novacort GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE20 mg/g

OpenFDA Data

SPL SET ID:c5b94bde-6982-48e5-ab68-13bb91d3d112
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1293729
  • 1293727

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69646-704Novacorthydrocortisone 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
    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 [Novacort]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOVACORT
    NOVACORT
    78308205 3165927 Live/Registered
    Novum Pharma, LLC
    2003-10-01
    NOVACORT
    NOVACORT
    73207956 1143867 Dead/Cancelled
    Syntex (U.S.A.) Inc.
    1979-03-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.