adapalene and benzoyl peroxide gel, 0.1%/2.5%

Generic: adapalene and benzoyl peroxide gel, 0.1%/2.5%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide gel, 0.1%/2.5%
Generic Name adapalene and benzoyl peroxide gel, 0.1%/2.5%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g, benzoyl peroxide 25 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-052
Product ID 21922-052_3161a0a4-5ec1-4810-8122-b3d94dcda3c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206164
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922052
Hyphenated Format 21922-052

Supplemental Identifiers

RxCUI
829539
UPC
0321922052503
UNII
1L4806J2QF W9WZN9A0GM
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name adapalene and benzoyl peroxide gel, 0.1%/2.5% (source: ndc)
Generic Name adapalene and benzoyl peroxide gel, 0.1%/2.5% (source: ndc)
Application Number ANDA206164 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

21922-052-50 1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP

Ingredients (2)

adapalene (1 mg/g) benzoyl peroxide (25 mg/g)

Linked Drug Pages (1)

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3161a0a4-5ec1-4810-8122-b3d94dcda3c5", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0321922052503"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539"], "spl_set_id": ["66858a82-cfda-4ba9-aac7-cf65499f4b1a"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (21922-052-50)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "21922-052-50", "marketing_start_date": "20230814"}], "brand_name": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%", "product_id": "21922-052_3161a0a4-5ec1-4810-8122-b3d94dcda3c5", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "21922-052", "generic_name": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "ANDA206164", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}