NDC 64980-301

Proctozone HC

Hydrocortisone

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 ID64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4
NDC64980-301
Product TypeHuman Prescription Drug
Proprietary NameProctozone HC
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA089682
Labeler NameRising Pharmaceuticals, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64980-301-30

1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE
Marketing Start Date2012-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-301-30 [64980030130]

Proctozone HC CREAM
Marketing CategoryANDA
Application NumberANDA089682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-05-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:fcd4747b-3c54-4b2f-a6bc-eafa0cf7016e
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

    64980030130 PROCTOZONE-HC 2.5% CREAM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Proctozone HC" or generic name "Hydrocortisone"

    NDCBrand NameGeneric Name
    64980-301Proctozone HCProctozone HC
    0096-0732Aquanil HCHydrocortisone
    0113-0793basic care hydrocortisonehydrocortisone
    0113-7369basic care hydrocortisoneHydrocortisone
    0113-7006Basic Case Hydrocortisone Anti-Itchhydrocortisone
    0009-0012CORTEFhydrocortisone
    0009-0031CORTEFhydrocortisone
    0009-0044CORTEFhydrocortisone
    0113-0471Good Sense Anti Itchhydrocortisone
    0113-0541good sense anti itchHydrocortisone
    0113-0973Good Sense Anti Itchhydrocortisone
    0113-1369good sense anti itchHydrocortisone
    0115-1696HYDROCORTISONEhydrocortisone
    0115-1697HYDROCORTISONEhydrocortisone
    0115-1700HYDROCORTISONEhydrocortisone
    0143-1252HydrocortisoneHydrocortisone
    0143-1253HydrocortisoneHydrocortisone
    0143-1254HydrocortisoneHydrocortisone
    0168-0014HYDROCORTISONEHYDROCORTISONE
    0168-0015hydrocortisoneHydrocortisone
    0168-0016HYDROCORTISONEHYDROCORTISONE
    0168-0020HydrocortisoneHydrocortisone
    0168-0080HydrocortisoneHydrocortisone
    0168-0146HydrocortisoneHydrocortisone
    0168-0154HYDROCORTISONEHYDROCORTISONE
    0168-0181HYDROCORTISONEHYDROCORTISONE
    0168-0288Hydrocortisonehydrocortisone

    Trademark Results [Proctozone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCTOZONE
    PROCTOZONE
    98629254 not registered Live/Pending
    Rising Pharma Holdings, Inc.
    2024-07-02
    PROCTOZONE
    PROCTOZONE
    75748935 not registered Dead/Abandoned
    IMX PHARMACEUTICALS INC.
    1999-07-01
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