adapalene and benzoyl peroxide

Generic: adapalene and benzoyl peroxide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene and benzoyl peroxide
Generic Name adapalene and benzoyl peroxide
Labeler bryant ranch prepack
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene .1 g/100g, benzoyl peroxide 2.5 g/100g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8607
Product ID 63629-8607_d3ca7d42-bc5b-41c2-93f2-83a55d5f2ab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205033
Listing Expiration 2026-12-31
Marketing Start 2018-01-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298607
Hyphenated Format 63629-8607

Supplemental Identifiers

RxCUI
829539
UNII
1L4806J2QF W9WZN9A0GM
NUI
N0000175607 M0018962

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 ANDA205033 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 g/100g
  • 2.5 g/100g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (63629-8607-1) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

63629-8607-1 1 BOTTLE, PUMP in 1 CARTON (63629-8607-1) / 45 g in 1 BOTTLE, PUMP

Ingredients (2)

adapalene (.1 g/100g) benzoyl peroxide (2.5 g/100g)

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": "d3ca7d42-bc5b-41c2-93f2-83a55d5f2ab5", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539"], "spl_set_id": ["c2b4c7a4-05e5-4e94-9f09-7f8f68f99eab"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (63629-8607-1)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "63629-8607-1", "marketing_start_date": "20180124"}], "brand_name": "adapalene and benzoyl peroxide", "product_id": "63629-8607_d3ca7d42-bc5b-41c2-93f2-83a55d5f2ab5", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "63629-8607", "generic_name": "Adapalene and Benzoyl Peroxide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "adapalene and benzoyl peroxide", "active_ingredients": [{"name": "ADAPALENE", "strength": ".1 g/100g"}, {"name": "BENZOYL PEROXIDE", "strength": "2.5 g/100g"}], "application_number": "ANDA205033", "marketing_category": "ANDA", "marketing_start_date": "20180124", "listing_expiration_date": "20261231"}