NDC 0168-0381

Prednicarbate

Prednicarbate

Prednicarbate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Prednicarbate.

Product ID0168-0381_82071531-988c-479b-8128-b482409ca90d
NDC0168-0381
Product TypeHuman Prescription Drug
Proprietary NamePrednicarbate
Generic NamePrednicarbate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2006-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA077287
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NamePREDNICARBATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0168-0381-60

60 g in 1 TUBE (0168-0381-60)
Marketing Start Date2006-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0381-60 [00168038160]

Prednicarbate CREAM
Marketing CategoryANDA
Application NumberANDA077287
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-09-19
Inactivation Date2020-01-31

NDC 0168-0381-15 [00168038115]

Prednicarbate CREAM
Marketing CategoryANDA
Application NumberANDA077287
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-09-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PREDNICARBATE1 mg/g

OpenFDA Data

SPL SET ID:89831c07-3a37-446e-b486-a7beb4cc227f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198363

    • Pharmacological Class

    • 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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