NDC 10631-407

Proctosol-HC

Hydrocortisone

Proctosol-HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Hydrocortisone.

Product ID10631-407_297a7b51-8e62-40c1-8691-0b6173918414
NDC10631-407
Product TypeHuman Prescription Drug
Proprietary NameProctosol-HC
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2005-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA088799
Labeler NameSun Pharmaceutical Industries, 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 10631-407-01

1 TUBE in 1 CARTON (10631-407-01) > 28.35 g in 1 TUBE
Marketing Start Date2005-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-407-01 [10631040701]

Proctosol-HC CREAM
Marketing CategoryANDA
Application NumberANDA088799
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2005-04-28

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:565284e7-4994-486b-8267-18bd166655ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310891
  • 1540356

    • Pharmacological Class

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

    Medicade Reported Pricing

    10631040701 PROCTOSOL-HC 2.5% CREAM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Proctosol-HC" or generic name "Hydrocortisone"

    NDCBrand NameGeneric Name
    10631-407Proctosol-HCProctosol-HC
    50090-1549Proctosol-HCProctosol-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 [Proctosol-HC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCTOSOL-HC
    PROCTOSOL-HC
    74293168 1757958 Live/Registered
    SUN PHARMACEUTICAL INDUSTRIES, INC.
    1992-07-13
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