adapalene and benzoyl peroxide

Generic: adapalene and benzoyl peroxide

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide
Generic Name adapalene and benzoyl peroxide
Labeler mayne pharma inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g, benzoyl peroxide 25 mg/g

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 68308-662
Product ID 68308-662_9d93fe57-cd04-40ff-abe4-a18c27768f9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA207917
Listing Expiration 2026-12-31
Marketing Start 2022-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308662
Hyphenated Format 68308-662

Supplemental Identifiers

RxCUI
1663745
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 (source: ndc)
Generic Name adapalene and benzoyl peroxide (source: ndc)
Application Number NDA207917 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68308-662-45) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

68308-662-45 1 BOTTLE, PUMP in 1 CARTON (68308-662-45) / 45 g in 1 BOTTLE, PUMP

Ingredients (2)

adapalene (3 mg/g) benzoyl peroxide (25 mg/g)

Linked Drug Pages (1)

adapalene and benzoyl peroxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "9d93fe57-cd04-40ff-abe4-a18c27768f9c", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745"], "spl_set_id": ["56541736-c70e-4fcd-9614-6cfdc5044136"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-662-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "68308-662-45", "marketing_start_date": "20220201"}], "brand_name": "adapalene and benzoyl peroxide", "product_id": "68308-662_9d93fe57-cd04-40ff-abe4-a18c27768f9c", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68308-662", "generic_name": "adapalene and benzoyl peroxide", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "adapalene and benzoyl peroxide", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "NDA207917", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220201", "listing_expiration_date": "20261231"}