Adapalene Topical Solution

Product NDC
49908-117
11-digit product format
499080117
Labeler code
49908
Product ID
49908-117_ea278171-964e-7750-e053-2a95a90a5aba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene Topical Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
CALL INC (d.b.a Rochester Pharmaceuticals)
Application
ANDA203981
Marketing category
ANDA
Marketing start
2021-12-13
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
1 mg/mL
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
49908-117-702025-01-30C16284748780-12cef2736-a04d-d83d-e063-dadaa90ab31fAdapalene Topical Solution 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49908-117-70Adapalene Topical Solution120 mL in 1 CARTONSOLUTION1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49908-117-70ML - Milliliter49908-1179a95a144-b6e7-4d3e-9199-f8d7ad5529c812022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49908-117ADAPALENE TOPICAL SOLUTION SOLUTION [CALL INC (D.B.A ROCHESTER PHARMACEUTICALS)]3Legacy NDC, 1 package rows20231003_d30d225c-65cc-7769-e053-2995a90a98d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307732adapalene 0.1 % Topical SolutionPSNd30d225c-65cc-7769-e053-2995a90a98d63
307732adapalene 1 MG/ML Topical SolutionSCDd30d225c-65cc-7769-e053-2995a90a98d63
307732adapalene 0.1 % Topical SolutionSYd30d225c-65cc-7769-e053-2995a90a98d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49908-117-7049908011770120 mL in 1 CARTON (49908-117-70) 120 ml2021-12-130000-00-00NoNoCurrent