FDA.reportPublic FDA data

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Product NDC
21922-052
11-digit product format
219220052
Labeler code
21922
Product ID
21922-052_3161a0a4-5ec1-4810-8122-b3d94dcda3c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
Dosage form
GEL
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA206164
Marketing category
ANDA
Marketing start
2023-08-14
Substance
ADAPALENE; BENZOYL PEROXIDE
Active strength
1; 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 Gel, 0.1%/2.5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g
BENZOYL PEROXIDE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF, W9WZN9A0GM

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
21922-052-50Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%45 g in 1 BOTTLE, PUMPGEL452
21922-052-50Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-052-50GM - Gram21922-052f23e8ec6-7068-446a-a101-4ddc998c9fcd12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-052ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5% GEL [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 2 package rows20230818_66858a82-cfda-4ba9-aac7-cf65499f4b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSN049ea4d9-c60e-4406-b199-da5abe92eced101
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCD049ea4d9-c60e-4406-b199-da5abe92eced101
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSY049ea4d9-c60e-4406-b199-da5abe92eced101
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSN66858a82-cfda-4ba9-aac7-cf65499f4b1a2
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCD66858a82-cfda-4ba9-aac7-cf65499f4b1a2
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSY66858a82-cfda-4ba9-aac7-cf65499f4b1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21922-052-50219220052501 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP2023-08-14NoNoCurrent