Adapalene

Product NDC
49967-354
11-digit product format
499670354
Labeler code
49967
Product ID
49967-354_ad1c20be-a838-45e9-9667-40a06e3b6f6a
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
ANDA091314
Marketing category
ANDA
Marketing start
2019-09-18
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adapalene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui307731

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-354-01Adapalene45 g in 1 TUBEGEL452
49967-354-01Adapalene1 in 1 CARTONGEL12
49967-354-02Adapalene15 g in 1 TUBEGEL152
49967-354-02Adapalene1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-354ADAPALENE GEL [L’OREAL USA PRODUCTS INC]2Current NDC, Legacy NDC, 4 package rows20230118_24e0fd2f-05dc-4ff4-838f-ee022a3a9c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN24e0fd2f-05dc-4ff4-838f-ee022a3a9c202
307731adapalene 0.001 MG/MG Topical GelSCD24e0fd2f-05dc-4ff4-838f-ee022a3a9c202
307731adapalene 0.1 % Topical GelSY24e0fd2f-05dc-4ff4-838f-ee022a3a9c202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-354-01499670354011 TUBE in 1 CARTON (49967-354-01) / 45 g in 1 TUBE1 tube2019-11-290000-00-00NoNoCurrent
49967-354-02499670354021 TUBE in 1 CARTON (49967-354-02) / 15 g in 1 TUBE1 tube2019-09-180000-00-00NoNoCurrent