FDA.reportPublic FDA data

ADAPALENE

Product NDC
68308-666
11-digit product format
683080666
Labeler code
68308
Product ID
68308-666_86366747-19bc-4279-8e62-afc7c8682e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ADAPALENE
Dosage form
GEL
Route
TOPICAL
Labeler
Mayne Pharma Commercial LLC.
Application
NDA021753
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-02-26
Substance
ADAPALENE
Active strength
3 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
ADAPALENE3 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui722111

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
68308-666-25ADAPALENE1 in 1 CARTONGEL11
68308-666-25ADAPALENE45 g in 1 TUBEGEL451
68308-666-45ADAPALENE45 g in 1 BOTTLE, PUMPGEL451
68308-666-45ADAPALENE1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-666ADAPALENE GEL [MAYNE PHARMA COMMERCIAL LLC.]1Current NDC, 4 package rows20240226_9a0d9a0d-a9f3-4eb9-be76-166ef182d13a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722111adapalene 0.3 % Topical GelPSN9a0d9a0d-a9f3-4eb9-be76-166ef182d13a1
722111adapalene 0.003 MG/MG Topical GelSCD9a0d9a0d-a9f3-4eb9-be76-166ef182d13a1
722111adapalene 0.3 % Topical GelSY9a0d9a0d-a9f3-4eb9-be76-166ef182d13a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68308-666-25683080666251 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE1 tube2024-02-26NoNoCurrent
68308-666-45683080666451 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMP2024-02-26NoNoCurrent