NDC 69007-918

adapalene

Adapalene

adapalene is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Owen Laboratories, Inc.. The primary component is Adapalene.

Product ID69007-918_ec947b61-6e3b-4444-9167-cab3cccfb6a7
NDC69007-918
Product TypeHuman Prescription Drug
Proprietary Nameadapalene
Generic NameAdapalene
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2009-09-15
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021753
Labeler NameOwen Laboratories, Inc.
Substance NameADAPALENE
Active Ingredient Strength3 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69007-918-25

1 BOTTLE, PUMP in 1 CARTON (69007-918-25) > 45 g in 1 BOTTLE, PUMP
Marketing Start Date2009-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69007-918-25 [69007091825]

adapalene GEL
Marketing CategoryNDA authorized generic
Application NumberNDA021753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-12-04
Marketing End Date2018-03-01

NDC 69007-918-45 [69007091845]

adapalene GEL
Marketing CategoryNDA authorized generic
Application NumberNDA021753
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-15
Marketing End Date2015-02-12

Drug Details

Active Ingredients

IngredientStrength
ADAPALENE3 mg/g

OpenFDA Data

SPL SET ID:79bf9131-d407-4cb3-bfc7-224a751d6e3e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722111
  • 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

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