Adapalene

Product NDC
72162-1048
11-digit product format
721621048
Labeler code
72162
Product ID
72162-1048_c9e91243-b1c9-457f-9172-e32010ebe9eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA090824
Marketing category
ANDA
Marketing start
2010-06-30
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adapalene
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui313852

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
72162-1048-2Adapalene45 g in 1 TUBECREAM45102
72162-1048-2Adapalene1 in 1 CARTONCREAM1102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1048ADAPALENE CREAM [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240302_79454b4c-3fd4-4e6d-b984-908f8cc8ab6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313852adapalene 0.1 % Topical CreamPSN79454b4c-3fd4-4e6d-b984-908f8cc8ab6d102
313852adapalene 1 MG/ML Topical CreamSCD79454b4c-3fd4-4e6d-b984-908f8cc8ab6d102
313852adapalene 0.1 % Topical CreamSY79454b4c-3fd4-4e6d-b984-908f8cc8ab6d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1048-2721621048021 TUBE in 1 CARTON (72162-1048-2) / 45 g in 1 TUBE1 tube2024-02-23NoNoHistorical