FDA.reportPublic FDA data

adapalene

Product NDC
0472-0126
11-digit product format
004720126
Labeler code
0472
Product ID
0472-0126_9bada4fd-f276-4355-bed1-ae5eee087c95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA201000
Marketing category
ANDA
Marketing start
2014-10-27
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
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
0472-0126-45adapalene45 g in 1 TUBEGEL458
0472-0126-45adapalene1 in 1 CARTONGEL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0126-45GM - Gram0472-012697550b89-74b8-406e-bcb8-d7fee45f779912014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADAPALENEACTIVE INGREDIENT1L4806J2QFADAPALENE GEL [ACTAVIS PHARMA, INC.]2
ADAPALENEACTIVE MOIETY1L4806J2QFADAPALENE GEL [ACTAVIS PHARMA, INC.]2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EADAPALENE GEL [ACTAVIS PHARMA, INC.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUADAPALENE GEL [ACTAVIS PHARMA, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBADAPALENE GEL [ACTAVIS PHARMA, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADAPALENE GEL [ACTAVIS PHARMA, INC.]2
POLOXAMER 182INACTIVE INGREDIENTJX0HIX6OAGADAPALENE GEL [ACTAVIS PHARMA, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADAPALENE GEL [ACTAVIS PHARMA, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IADAPALENE GEL [ACTAVIS PHARMA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RADAPALENE GEL [ACTAVIS PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0126ADAPALENE GEL [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20240617_aacd5ec4-e2fa-460e-aaae-a0aba5c052e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722111adapalene 0.3 % Topical GelPSNaacd5ec4-e2fa-460e-aaae-a0aba5c052e58
722111adapalene 0.003 MG/MG Topical GelSCDaacd5ec4-e2fa-460e-aaae-a0aba5c052e58
722111adapalene 0.3 % Topical GelSYaacd5ec4-e2fa-460e-aaae-a0aba5c052e58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0126-45004720126451 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE1 tube2014-10-270000-00-00NoNoCurrent