NDC 0168-0410

Prednicarbate

Prednicarbate

Prednicarbate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is Prednicarbate.

Product ID0168-0410_356d0555-54ad-46a8-b35f-726ef9894420
NDC0168-0410
Product TypeHuman Prescription Drug
Proprietary NamePrednicarbate
Generic NamePrednicarbate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2007-03-09
Marketing CategoryANDA / ANDA
Application NumberANDA077236
Labeler NameFougera Pharmaceuticals Inc.
Substance NamePREDNICARBATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0410-15

15 g in 1 TUBE (0168-0410-15)
Marketing Start Date2007-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0410-15 [00168041015]

Prednicarbate OINTMENT
Marketing CategoryANDA
Application NumberANDA077236
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-03-09

NDC 0168-0410-60 [00168041060]

Prednicarbate OINTMENT
Marketing CategoryANDA
Application NumberANDA077236
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-03-09

Drug Details

Active Ingredients

IngredientStrength
PREDNICARBATE1 mg/g

OpenFDA Data

SPL SET ID:e6bad712-16df-4f32-a8ea-f8b52e30de00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 706546
    • UPC Code
  • 0301680410159

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Prednicarbate" or generic name "Prednicarbate"

    NDCBrand NameGeneric Name
    0168-0381Prednicarbateprednicarbate
    0168-0410Prednicarbateprednicarbate
    68682-880Prednicarbateemollient
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