NDC 69007-912

adapalene

Adapalene

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

Product ID69007-912_37259cdb-ed05-4e36-9ff6-e67b41cad7d7
NDC69007-912
Product TypeHuman Prescription Drug
Proprietary Nameadapalene
Generic NameAdapalene
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2010-03-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022502
Labeler NameOwen Laboratories, Inc.
Substance NameADAPALENE
Active Ingredient Strength0 g/100mL
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69007-912-02

1 BOTTLE, PUMP in 1 CARTON (69007-912-02) > 59 mL in 1 BOTTLE, PUMP
Marketing Start Date2010-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69007-912-02 [69007091202]

adapalene LOTION
Marketing CategoryNDA authorized generic
Application NumberNDA022502
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-11-04
Marketing End Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
ADAPALENE.1 g/100mL

OpenFDA Data

SPL SET ID:f740915a-7392-4b52-a83c-e49e37021182
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905385
  • 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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