FDA.reportPublic FDA data

Adapalene Gel USP, 0.3%

Product NDC
72162-2295
11-digit product format
721622295
Labeler code
72162
Product ID
72162-2295_e725e42a-8a28-438f-8476-ce1e54ac33dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene Gel USP, 0.3%
Dosage form
GEL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA200298
Marketing category
ANDA
Marketing start
2023-05-05
Substance
ADAPALENE
Active strength
3 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 Gel USP, 0.3%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE3 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui722111

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
72162-2295-2Adapalene Gel USP, 0.3%1 in 1 CARTONGEL1101
72162-2295-2Adapalene Gel USP, 0.3%45 g in 1 TUBEGEL45101
72162-2295-4Adapalene Gel USP, 0.3%45 g in 1 BOTTLE, PUMPGEL45101
72162-2295-4Adapalene Gel USP, 0.3%1 in 1 CARTONGEL1101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2295-2GM - Gram72162-22951622a475-985b-455e-a874-f6823929cf2e12024-06-10
72162-2295-4GM - Gram72162-2295031427a0-2438-4e73-9251-51f80e5c1fa912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2295ADAPALENE GEL USP, 0.3% GEL [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20240502_c448eab6-c054-4c8b-9319-556b7e1be3cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722111adapalene 0.3 % Topical GelPSNc448eab6-c054-4c8b-9319-556b7e1be3cf101
722111adapalene 0.003 MG/MG Topical GelSCDc448eab6-c054-4c8b-9319-556b7e1be3cf101
722111adapalene 0.3 % Topical GelSYc448eab6-c054-4c8b-9319-556b7e1be3cf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2295-2721622295021 TUBE in 1 CARTON (72162-2295-2) / 45 g in 1 TUBE1 tube2024-04-30NoNoHistorical
72162-2295-4721622295041 BOTTLE, PUMP in 1 CARTON (72162-2295-4) / 45 g in 1 BOTTLE, PUMP2024-04-30NoNoHistorical