Adapalene

Product NDC
45802-453
11-digit product format
458020453
Labeler code
45802
Product ID
45802-453_0a564c3c-85dd-4fb8-8bb8-27a9e24c5723
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA020748
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-10-26
Substance
ADAPALENE
Active strength
.1 g/100g
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
ADAPALENE.1 g/100g

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
45802-453-84Adapalene45 g in 1 TUBECREAM454
45802-453-84Adapalene1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-453-84GM - Gram45802-453eee4a95a-3083-4a69-937c-3c8f490566b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADAPALENEACTIVE INGREDIENT1L4806J2QFADAPALENE CREAM [PERRIGO NEW YORK INC]2
ADAPALENEACTIVE MOIETY1L4806J2QFADAPALENE CREAM [PERRIGO NEW YORK INC]2
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31ADAPALENE CREAM [PERRIGO NEW YORK INC]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZADAPALENE CREAM [PERRIGO NEW YORK INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KADAPALENE CREAM [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADAPALENE CREAM [PERRIGO NEW YORK INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADAPALENE CREAM [PERRIGO NEW YORK INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TADAPALENE CREAM [PERRIGO NEW YORK INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHADAPALENE CREAM [PERRIGO NEW YORK INC]2
SQUALANEINACTIVE INGREDIENTGW89575KF9ADAPALENE CREAM [PERRIGO NEW YORK INC]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKADAPALENE CREAM [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RADAPALENE CREAM [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-453ADAPALENE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Current NDC, Legacy NDC, 2 package rows20230801_94cf9af1-afab-4064-a2ca-619b54218262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313852adapalene 0.1 % Topical CreamPSN94cf9af1-afab-4064-a2ca-619b542182624
313852adapalene 1 MG/ML Topical CreamSCD94cf9af1-afab-4064-a2ca-619b542182624
313852adapalene 0.1 % Topical CreamSY94cf9af1-afab-4064-a2ca-619b542182624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-453-84458020453841 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE1 tube2010-10-270000-00-00NoNoCurrent