NDC 0168-0424

Adapalene

Adapalene

Adapalene 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 Adapalene.

Product ID0168-0424_36fa34c8-7613-464b-ba53-1150bb7241a2
NDC0168-0424
Product TypeHuman Prescription Drug
Proprietary NameAdapalene
Generic NameAdapalene
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2010-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA090824
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameADAPALENE
Active Ingredient Strength1 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0424-46

1 TUBE in 1 CARTON (0168-0424-46) > 45 g in 1 TUBE
Marketing Start Date2010-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0424-46 [00168042446]

Adapalene CREAM
Marketing CategoryANDA
Application NumberANDA090824
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2010-06-30

Drug Details

Active Ingredients

IngredientStrength
ADAPALENE1 mg/g

OpenFDA Data

SPL SET ID:276f7cce-5f54-40f8-8321-9192d0e52a73
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313852

    • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]
    • Retinoid [EPC]
    • Retinoids [CS]

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

    NDCBrand NameGeneric Name
    0093-6301AdapaleneAdapalene
    0168-0424Adapaleneadapalene
    0363-0888AdapaleneAdapalene
    0472-0126adapaleneadapalene
    0781-7142AdapaleneAdapalene
    11673-888AdapaleneAdapalene
    21130-708AdapaleneAdapalene
    28595-530AdapaleneADAPALENE
    36800-088AdapaleneAdapalene
    41250-288AdapaleneAdapalene
    42546-720AdapaleneAdapalene
    45802-453AdapaleneAdapalene
    49908-118AdapaleneAdapalene
    49967-354AdapaleneAdapalene
    68462-403AdapaleneAdapalene
    69007-918adapaleneadapalene
    69007-912adapaleneadapalene
    50090-2004AdapaleneAdapalene
    51672-1377AdapaleneAdapalene
    51672-4155AdapaleneAdapalene
    66993-884ADAPALENEADAPALENE
    69842-088AdapaleneAdapalene
    55910-880AdapaleneAdapalene
    70000-0043AdapaleneAdapalene
    62332-549ADAPALENEADAPALENE
    71589-008ADAPALENEADAPALENE
    0682-0053Adapalene Topical SolutionAdapalene
    0299-4910DifferinAdapalene
    0299-5910DIFFERINadapalene
    0299-5912Differinadapalene
    0299-5915DifferinAdapalene
    0299-5918DIFFERINadapalene
    11410-956Proactiv MD AdapaleneAdapalene
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