Adapalene

Product NDC
59726-114
11-digit product format
597260114
Labeler code
59726
Product ID
59726-114_1475ee8f-99c8-4bfb-b17f-008a11672860
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
P & L Development, LLC
Application
ANDA090962
Marketing category
ANDA
Marketing start
2023-11-30
Marketing end
2027-03-30
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adapalene

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
59726-114-05Adapalene1 in 1 CARTONGEL13
59726-114-05Adapalene15 g in 1 TUBEGEL153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-114ADAPALENE GEL [P & L DEVELOPMENT, LLC]2Current NDC, 2 package rows20240223_e9155950-6c92-4f57-851a-51be6ba9062f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSNe9155950-6c92-4f57-851a-51be6ba9062f3
307731adapalene 0.001 MG/MG Topical GelSCDe9155950-6c92-4f57-851a-51be6ba9062f3
307731adapalene 0.1 % Topical GelSYe9155950-6c92-4f57-851a-51be6ba9062f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-114-05597260114051 TUBE in 1 CARTON (59726-114-05) / 15 g in 1 TUBE1 tube2023-11-302027-03-30NoNoHistorical