Adapalene

Product NDC
51672-2150
11-digit product format
516722150
Labeler code
51672
Product ID
51672-2150_35328d05-d4b5-7aac-e063-6294a90a2f8b
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA215940
Marketing category
ANDA
Marketing start
2022-01-14
Substance
ADAPALENE
Active strength
1 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
ADAPALENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui307731

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
51672-2150-1Adapalene15 g in 1 TUBEGEL156
51672-2150-1Adapalene1 in 1 CARTONGEL16
51672-2150-6Adapalene45 g in 1 TUBEGEL456
51672-2150-6Adapalene1 in 1 CARTONGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2150-1GM - Gram51672-2150e9853787-d745-44a1-b2ef-bc2815b9adac12025-08-11
51672-2150-6GM - Gram51672-21503434f184-cd91-4079-8317-ac182a10205412025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2150ADAPALENE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, 4 package rows20250521_a9ca1f7a-71c3-4814-9366-e7e5760bf32c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSNa9ca1f7a-71c3-4814-9366-e7e5760bf32c6
307731adapalene 0.001 MG/MG Topical GelSCDa9ca1f7a-71c3-4814-9366-e7e5760bf32c6
307731adapalene 0.1 % Topical GelSYa9ca1f7a-71c3-4814-9366-e7e5760bf32c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2150-1516722150011 TUBE in 1 CARTON (51672-2150-1) / 15 g in 1 TUBE1 tube2022-01-14NoNoHistorical
51672-2150-6516722150061 TUBE in 1 CARTON (51672-2150-6) / 45 g in 1 TUBE1 tube2022-01-14NoNoHistorical