NDC 65649-501

Proctocort

Hydrocortisone

Proctocort is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc. The primary component is Hydrocortisone.

Product ID65649-501_62bfc47a-1d14-4dd2-8020-56e01f4e89a7
NDC65649-501
Product TypeHuman Prescription Drug
Proprietary NameProctocort
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2004-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA080706
Labeler NameSalix Pharmaceuticals, Inc
Substance NameHYDROCORTISONE
Active Ingredient Strength10 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65649-501-30

1 TUBE in 1 CARTON (65649-501-30) > 28.35 g in 1 TUBE
Marketing Start Date2004-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65649-501-30 [65649050130]

Proctocort CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-06-01

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE10 mg/g

OpenFDA Data

SPL SET ID:8c318d15-30e4-4395-9aa9-4157d349fe70
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1865144
  • 106258
    • UPC Code
  • 0365649501302

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Proctocort" or generic name "Hydrocortisone"

    NDCBrand NameGeneric Name
    65649-501ProctocortProctocort
    65649-511ProctocortProctocort
    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 [Proctocort]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROCTOCORT
    PROCTOCORT
    75243921 2132640 Live/Registered
    SALIX PHARMACEUTICALS, INC.
    1997-02-19
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