FDA.reportPublic FDA data

Adapalene and Benzoyl Peroxide

Product NDC
51672-1384
11-digit product format
516721384
Labeler code
51672
Product ID
51672-1384_38efdb2e-a94e-0df0-e063-6394a90a98e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ADAPALENE and BENZOYL PEROXIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209148
Marketing category
ANDA
Marketing start
2018-10-17
Substance
ADAPALENE; BENZOYL PEROXIDE
Active strength
3; 25 mg/g; 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 and Benzoyl Peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE3 mg/g
BENZOYL PEROXIDE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF, W9WZN9A0GM
Rxcui1663745

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
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
51672-1384-4Adapalene and Benzoyl Peroxide1 in 1 CARTONGEL17
51672-1384-4Adapalene and Benzoyl Peroxide60 g in 1 BOTTLE, PUMPGEL607
51672-1384-9Adapalene and Benzoyl Peroxide45 g in 1 BOTTLE, PUMPGEL457
51672-1384-9Adapalene and Benzoyl Peroxide1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1384-9GM - Gram51672-1384f81c6006-a026-4346-bd1e-3ef43277a51212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1384ADAPALENE AND BENZOYL PEROXIDE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 4 package rows20250418_13fc72e9-7178-4a8b-9fe8-d88ba591dac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663745adapalene 0.3 % / benzoyl peroxide 2.5 % Topical GelPSN13fc72e9-7178-4a8b-9fe8-d88ba591dac87
1663745adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCD13fc72e9-7178-4a8b-9fe8-d88ba591dac87
1663745adapalene 0.3 % / benzoyl peroxide 2.5 % Topical GelSY13fc72e9-7178-4a8b-9fe8-d88ba591dac87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1384-4516721384041 BOTTLE, PUMP in 1 CARTON (51672-1384-4) / 60 g in 1 BOTTLE, PUMP2021-03-110000-00-00NoNoCurrent
51672-1384-9516721384091 BOTTLE, PUMP in 1 CARTON (51672-1384-9) / 45 g in 1 BOTTLE, PUMP2018-10-170000-00-00NoNoCurrent