NDC 0093-6301

Adapalene

Adapalene

Adapalene is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Adapalene.

Product ID0093-6301_16be5cbc-6e7f-4288-a14b-bd432509a319
NDC0093-6301
Product TypeHuman Prescription Drug
Proprietary NameAdapalene
Generic NameAdapalene
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2010-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA090962
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameADAPALENE
Active Ingredient Strength1 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-6301-95

45 g in 1 TUBE (0093-6301-95)
Marketing Start Date2010-06-02
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-6301-95 [00093630195]

Adapalene GEL
Marketing CategoryANDA
Application NumberANDA090962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2010-06-02

Drug Details

Active Ingredients

IngredientStrength
ADAPALENE1 mg/g

OpenFDA Data

SPL SET ID:36c8b3ad-3552-4e83-8a16-f20be7c39e4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 307731
  • Pharmacological Class

    • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.