NDC 64980-324

PROCTOZONE-HC

Hydrocortisone 2.5%

PROCTOZONE-HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Hydrocortisone.

Product ID64980-324_a9b749da-c294-4f95-9883-138f914a8ad9
NDC64980-324
Product TypeHuman Prescription Drug
Proprietary NamePROCTOZONE-HC
Generic NameHydrocortisone 2.5%
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA040879
Labeler NameRising Pharmaceuticals, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 64980-324-30

1 TUBE in 1 CARTON (64980-324-30) > 30 g in 1 TUBE
Marketing Start Date2015-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-324-30 [64980032430]

PROCTOZONE-HC CREAM
Marketing CategoryANDA
Application NumberANDA040879
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-08-03

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:fb5746ff-3ff1-4874-a827-4694133641b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1440936
  • 310891

    • Pharmacological Class

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

    Medicade Reported Pricing

    64980032430 PROCTOZONE-HC 2.5% CREAM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "PROCTOZONE-HC" or generic name "Hydrocortisone 2.5%"

    NDCBrand NameGeneric Name
    63629-2396PROCTOZONE-HChydrocortisone 2.5%
    63629-8847PROCTOZONE-HChydrocortisone 2.5%
    64980-324PROCTOZONE-HChydrocortisone 2.5%
    68071-2807PROCTOZONE-HChydrocortisone 2.5%
    68788-7091PROCTOZONE-HCHydrocortisone 2.5%

    Trademark Results [PROCTOZONE-HC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCTOZONE-HC
    PROCTOZONE-HC
    77188285 3384445 Live/Registered
    RISING PHARMACEUTICALS, INC.
    2007-05-23
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