NDC 21695-982

Proctofoam HC

Hydrocortisone Acetate And Pramoxine Hydrochloride

Proctofoam HC is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Hydrocortisone Acetate; Pramoxine Hydrochloride.

Product ID21695-982_14e43813-665c-4cef-b3b1-60eafc880f41
NDC21695-982
Product TypeHuman Prescription Drug
Proprietary NameProctofoam HC
Generic NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormAerosol, Foam
Route of AdministrationTOPICAL
Marketing Start Date1978-07-26
Marketing CategoryANDA / ANDA
Application NumberANDA086195
Labeler NameRebel Distributors Corp
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength100 mg/10g; mg/10g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-982-10

1 CONTAINER in 1 CARTON (21695-982-10) > 10 g in 1 CONTAINER
Marketing Start Date1978-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-982-10 [21695098210]

Proctofoam HC AEROSOL, FOAM
Marketing CategoryANDA
Application NumberANDA086195
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1978-07-26
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE ACETATE100 mg/10g

OpenFDA Data

SPL SET ID:14e43813-665c-4cef-b3b1-60eafc880f41
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828362
  • 828364
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0037-6822PROCTOFOAM HCPROCTOFOAM HC
    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 [Proctofoam]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCTOFOAM
    PROCTOFOAM
    72239316 0819021 Live/Registered
    REED & CARNRICK
    1966-02-21

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