Adapalene and Benzoyl Peroxide

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Taro Pharmaceuticals U.S.A., Inc.

DUNS Number

206263295

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

51672-1384

Application Number

ANDA209148

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

December 27, 2022

Ingredients

docusate sodiumInactive

Code: F05Q2T2JA0Class: IACT

Code: 1L4806J2QFClass: ACTIBQuantity: 3 mg in 1 g

Code: W9WZN9A0GMClass: ACTIBQuantity: 25 mg in 1 g

poloxamer 124Inactive

Code: 1S66E28KXAClass: IACT

edetate disodiumInactive

Code: 7FLD91C86KClass: IACT

glycerinInactive

Code: PDC6A3C0OXClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)Inactive

Code: 5F4963KLHSClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT