NDC 69315-302

Procto-Med HC

Hydrocortisone

Procto-Med HC is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Hydrocortisone.

Product ID69315-302_d4bcf8db-c5e5-42d5-96b2-d5df7ed50555
NDC69315-302
Product TypeHuman Prescription Drug
Proprietary NameProcto-Med HC
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA089682
Labeler NameLeading Pharma, LLC
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 69315-302-30

1 TUBE in 1 CARTON (69315-302-30) > 30 g in 1 TUBE
Marketing Start Date2016-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69315-302-30 [69315030230]

Procto-Med HC CREAM
Marketing CategoryANDA
Application NumberANDA089682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-05-09

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:8548507e-616b-4ea6-bcc4-5cafd0a4b2e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790684
  • 310891

    • Pharmacological Class

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

    Medicade Reported Pricing

    69315030230 PROCTO-MED HC 2.5% CREAM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Procto-Med HC" or generic name "Hydrocortisone"

    NDCBrand NameGeneric Name
    68071-3333Procto-Med HCProcto-Med HC
    69315-302Procto-Med HCProcto-Med HC
    50090-2931Procto-Med HCProcto-Med HC
    69315-312Procto-Med HCProcto-Med HC
    68071-2261Procto-Med HCProcto-Med 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
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