FDA.reportPublic FDA data

Adapalene

Product NDC
69842-088
11-digit product format
698420088
Labeler code
69842
Product ID
69842-088_be700323-f4e6-4b29-99f8-b07264a14bbd
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
CVS Pharmacy
Application
ANDA091314
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
2026-12-31
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
69842-088-052023-01-18C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-162023-01-18C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-052020-09-27C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-162020-09-27C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-052020-09-25C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-162020-09-25C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-052020-07-22C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED
69842-088-162020-07-22C16284748780-1ab0e2407-3082-f274-e053-dbdaa90a6471Adapalene Gel DELISTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-088-05Adapalene1 in 1 CARTONGEL111
69842-088-05Adapalene15 g in 1 TUBEGEL1511
69842-088-16Adapalene1 in 1 CARTONGEL111
69842-088-16Adapalene45 g in 1 TUBEGEL4511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-088-05GM - Gram69842-08879533c6c-91cf-4b1e-818d-910d45f230fc12023-04-07
69842-088-16GM - Gram69842-0888d99e175-b3bf-47da-95f6-bf0a192f2e9012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-088ADAPALENE GEL [CVS PHARMACY]9Current NDC, Legacy NDC, 4 package rows20230306_7fb758ce-4f15-4130-8612-9113a764b5cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN7fb758ce-4f15-4130-8612-9113a764b5cd11
307731adapalene 0.001 MG/MG Topical GelSCD7fb758ce-4f15-4130-8612-9113a764b5cd11
307731adapalene 0.1 % Topical GelSY7fb758ce-4f15-4130-8612-9113a764b5cd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-088-05698420088051 TUBE in 1 CARTON (69842-088-05) / 15 g in 1 TUBE1 tube2019-08-012026-12-31NoNoHistorical
69842-088-16698420088161 TUBE in 1 CARTON (69842-088-16) / 45 g in 1 TUBE1 tube2019-08-012026-12-31NoNoHistorical