FDA.reportPublic FDA data

ADAPALENE

Product NDC
70000-0666
11-digit product format
700000666
Labeler code
70000
Product ID
70000-0666_38f4a9bd-570f-8514-e063-6294a90ae816
Type
HUMAN OTC DRUG
Nonproprietary name
ADAPALENE
Dosage form
GEL
Route
TOPICAL
Labeler
Cardinal Health
Application
ANDA215940
Marketing category
ANDA
Marketing start
2024-03-17
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
70000-0666-1ADAPALENE1 in 1 CARTONGEL12
70000-0666-1ADAPALENE15 g in 1 TUBEGEL152
70000-0666-2ADAPALENE45 g in 1 TUBEGEL452
70000-0666-2ADAPALENE1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0666-2GM - Gram70000-06667db384d8-bb4b-4da4-94e7-b6874beb546912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0666ADAPALENE GEL [CARDINAL HEALTH]1Current NDC, 4 package rows20240328_d894d7ce-4c44-4092-88dd-8e8f7ef777f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSNd894d7ce-4c44-4092-88dd-8e8f7ef777f22
307731adapalene 0.001 MG/MG Topical GelSCDd894d7ce-4c44-4092-88dd-8e8f7ef777f22
307731adapalene 0.1 % Topical GelSYd894d7ce-4c44-4092-88dd-8e8f7ef777f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0666-1700000666011 TUBE in 1 CARTON (70000-0666-1) / 15 g in 1 TUBE1 tube2024-03-17NoNoHistorical
70000-0666-2700000666021 TUBE in 1 CARTON (70000-0666-2) / 45 g in 1 TUBE1 tube2024-03-17NoNoHistorical