Adapalene

Product NDC
55910-880
11-digit product format
559100880
Labeler code
55910
Product ID
55910-880_64d9409f-7bb1-40b5-b961-f95abdb82c06
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA091314
Marketing category
ANDA
Marketing start
2019-11-29
Marketing end
2026-11-29
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-880-052023-10-10C16284748780-1f386c64a-18e7-0266-e053-dadaa90a7c1aAdapalene Gel USP 0 1 percent DELISTED
55910-880-052023-01-30C16284748780-1f386c64a-18e7-0266-e053-dadaa90a7c1aAdapalene Gel USP 0 1 percent DELISTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-880-05Adapalene1 in 1 CARTONGEL14
55910-880-05Adapalene15 g in 1 TUBEGEL154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-880ADAPALENE GEL [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Current NDC, Legacy NDC, 2 package rows20231011_62fab99a-f91b-4f0f-9143-9c9bc69df759.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN62fab99a-f91b-4f0f-9143-9c9bc69df7594
307731adapalene 0.001 MG/MG Topical GelSCD62fab99a-f91b-4f0f-9143-9c9bc69df7594
307731adapalene 0.1 % Topical GelSY62fab99a-f91b-4f0f-9143-9c9bc69df7594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-880-05559100880051 TUBE in 1 CARTON (55910-880-05) / 15 g in 1 TUBE1 tube2019-11-292026-11-29NoNoCurrent