FDA.reportPublic FDA data

Adapalene Gel USP, 0.3%

Product NDC
21922-051
11-digit product format
219220051
Labeler code
21922
Product ID
21922-051_2e5f2180-7624-4bb6-892d-e63491da2591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene Gel USP, 0.3%
Dosage form
GEL
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA200298
Marketing category
ANDA
Marketing start
2023-08-07
Substance
ADAPALENE
Active strength
3 mg/g
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 Gel USP, 0.3%
Listing expiration
2026-12-31

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
21922-051-06Adapalene Gel USP, 0.3%1 in 1 CARTONGEL15
21922-051-06Adapalene Gel USP, 0.3%45 g in 1 TUBEGEL455
21922-051-50Adapalene Gel USP, 0.3%45 g in 1 BOTTLE, PUMPGEL455
21922-051-50Adapalene Gel USP, 0.3%1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-051-06GM - Gram21922-0517000e1f2-1258-4997-bd35-4a1e230ca0ea12023-06-06
21922-051-50GM - Gram21922-051f95a6392-f175-4e60-8da3-e16c76f5b67d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-051ADAPALENE GEL USP, 0.3% GEL [ENCUBE ETHICALS PRIVATE LIMITED]4Current NDC, 4 package rows20241226_56045eee-e84d-467a-9e12-e62bd474ed8a.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
722111adapalene 0.3 % Topical GelPSN56045eee-e84d-467a-9e12-e62bd474ed8a5
722111adapalene 0.003 MG/MG Topical GelSCD56045eee-e84d-467a-9e12-e62bd474ed8a5
722111adapalene 0.3 % Topical GelSY56045eee-e84d-467a-9e12-e62bd474ed8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-051-06219220051061 TUBE in 1 CARTON (21922-051-06) / 45 g in 1 TUBE1 tube2023-08-10NoNoCurrent
21922-051-50219220051501 BOTTLE, PUMP in 1 CARTON (21922-051-50) / 45 g in 1 BOTTLE, PUMP2023-08-10NoNoCurrent