Adapalene

Product NDC
72657-158
11-digit product format
726570158
Labeler code
72657
Product ID
72657-158_52ea6426-f743-4a3f-b927-5940f4428593
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA091314
Marketing category
ANDA
Marketing start
2023-03-10
Substance
ADAPALENE
Active strength
1 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
Listing expiration
2027-12-31

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
72657-158-17Adapalene15 g in 1 TUBEGEL155
72657-158-17Adapalene1 in 1 CARTONGEL15
72657-158-55Adapalene45 g in 1 TUBEGEL455
72657-158-55Adapalene1 in 1 CARTONGEL15
72657-158-15Adapalene15 g in 1 BOTTLE, PUMPGEL151
72657-158-15Adapalene1 in 1 CARTONGEL11
72657-158-45Adapalene1 in 1 CARTONGEL11
72657-158-45Adapalene45 g in 1 BOTTLE, PUMPGEL451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-158-17GM - Gram72657-158ffe8760d-71af-40ef-adc8-b4bd2b03ca6d12025-12-16
72657-158-55GM - Gram72657-1588e8bd92d-776e-4c94-a3bc-7fa6007dc63112025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-158ADAPALENE GEL [GLENMARK THERAPEUTICS INC., USA]4Current NDC, 4 package rows20240726_42c1c354-2c00-4bc2-bbd3-a5dd5ff9a208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN42c1c354-2c00-4bc2-bbd3-a5dd5ff9a2085
307731adapalene 0.001 MG/MG Topical GelSCD42c1c354-2c00-4bc2-bbd3-a5dd5ff9a2085
307731adapalene 0.1 % Topical GelSY42c1c354-2c00-4bc2-bbd3-a5dd5ff9a2085
307731adapalene 0.1 % Topical GelPSNec6811f7-4728-41b1-8647-d63bb135e24e1
307731adapalene 0.001 MG/MG Topical GelSCDec6811f7-4728-41b1-8647-d63bb135e24e1
307731adapalene 0.1 % Topical GelSYec6811f7-4728-41b1-8647-d63bb135e24e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-158-15726570158151 BOTTLE, PUMP in 1 CARTON (72657-158-15) / 15 g in 1 BOTTLE, PUMP2025-03-14NoNoCurrent
72657-158-17726570158171 TUBE in 1 CARTON (72657-158-17) / 15 g in 1 TUBE1 tube2023-03-10NoNoCurrent
72657-158-45726570158451 BOTTLE, PUMP in 1 CARTON (72657-158-45) / 45 g in 1 BOTTLE, PUMP2025-03-14NoNoCurrent
72657-158-55726570158551 TUBE in 1 CARTON (72657-158-55) / 45 g in 1 TUBE1 tube2023-03-10NoNoCurrent