FDA.reportPublic FDA data

Adapalene

Product NDC
49908-118
11-digit product format
499080118
Labeler code
49908
Product ID
49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene
Dosage form
SWAB
Route
TOPICAL
Labeler
CALL INC. (dba Rochester Pharmaceuticals)
Application
ANDA204593
Marketing category
ANDA
Marketing start
2019-02-04
Substance
ADAPALENE
Active strength
1 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui798061

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
49908-118-142022-10-03C16284748780-1d6a99b39-7f38-a426-e053-dadaa90af4c2Adapalene Topical Solution, 0.1%
49908-118-142022-01-28C16284748780-1d6a99b39-7f38-a426-e053-dadaa90af4c2Adapalene Topical Solution, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49908-118-00Adapalene1.2 mL in 1 POUCHSWAB1.27
49908-118-14Adapalene14 in 1 CARTONSWAB147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49908-118-14EA - Each49908-11890946805-da58-4e8a-b52a-b0f6b5b33fd712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49908-118ADAPALENE SWAB [CALL INC. (DBA ROCHESTER PHARMACEUTICALS)]7Current NDC, Legacy NDC, 2 package rows20250110_5ce78048-0e5c-45b5-82bf-9f61307611cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798061adapalene 0.1 % Medicated PadPSN5ce78048-0e5c-45b5-82bf-9f61307611cd7
798061adapalene 1 MG/ML Medicated PadSCD5ce78048-0e5c-45b5-82bf-9f61307611cd7
798061adapalene 0.1 % Medicated PadSY5ce78048-0e5c-45b5-82bf-9f61307611cd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49908-118-00499080118001.2 mL in 1 POUCH1.2 mlHistorical
49908-118-144990801181414 POUCH in 1 CARTON (49908-118-14) / 1.2 mL in 1 POUCH (49908-118-00) 14 pouch2019-02-040000-00-00NoNoCurrent