NDC 49908-118

Adapalene

Adapalene

Adapalene is a Topical Swab in the Human Prescription Drug category. It is labeled and distributed by Call Inc. (dba Rochester Pharmaceuticals). The primary component is Adapalene.

Product ID49908-118_80363d72-bf7c-2a23-e053-2991aa0a9f28
NDC49908-118
Product TypeHuman Prescription Drug
Proprietary NameAdapalene
Generic NameAdapalene
Dosage FormSwab
Route of AdministrationTOPICAL
Marketing Start Date2019-02-04
Marketing CategoryANDA / ANDA
Application NumberANDA204593
Labeler NameCALL INC. (dba Rochester Pharmaceuticals)
Substance NameADAPALENE
Active Ingredient Strength1 mg/mL
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49908-118-14

14 POUCH in 1 CARTON (49908-118-14) > 1.2 mL in 1 POUCH (49908-118-00)
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49908-118-14 [49908011814]

Adapalene SWAB
Marketing CategoryANDA
Application NumberANDA204593
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-04

NDC 49908-118-00 [49908011800]

Adapalene SWAB
Marketing CategoryANDA
Application NumberANDA204593
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

NDC 49908-118-60 [49908011860]

Adapalene SWAB
Marketing CategoryANDA
Application NumberANDA204593
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-04
Marketing End Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
ADAPALENE1 mg/mL

OpenFDA Data

SPL SET ID:5ce78048-0e5c-45b5-82bf-9f61307611cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 798061

    • 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.