FDA.reportPublic FDA data

adapalene and benzoyl peroxide

Product NDC
68462-301
11-digit product format
684620301
Labeler code
68462
Product ID
68462-301_194a1ade-7163-4a56-ad50-6220398ede14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene and benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA208108
Marketing category
ANDA
Marketing start
2019-11-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
adapalene and benzoyl peroxide
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
Rxcui829539

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
68462-301-47adapalene and benzoyl peroxide1 in 1 CARTONGEL15
68462-301-47adapalene and benzoyl peroxide45 g in 1 BOTTLE, PUMPGEL455
68462-301-55adapalene and benzoyl peroxide45 g in 1 TUBEGEL455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-301-47GM - Gram68462-3012460d6b3-6a08-4e12-9089-a9ec0b4da78e12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-301ADAPALENE AND BENZOYL PEROXIDE GEL [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 3 package rows20230111_fc8e868f-9699-4ae6-83d5-fa27789336cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSNfc8e868f-9699-4ae6-83d5-fa27789336cd5
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCDfc8e868f-9699-4ae6-83d5-fa27789336cd5
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSYfc8e868f-9699-4ae6-83d5-fa27789336cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-301-47684620301471 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP2019-11-080000-00-00NoNoCurrent
68462-301-556846203015545 g in 1 TUBE (68462-301-55) 45 g2019-11-080000-00-00NoNoCurrent