Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Generic: Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Labeler: GABAR HEALTH SCIENCES CORP
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

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 GABAR HEALTH SCIENCES CORP
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

ADAPALENE 1 mg/g, BENZOYL PEROXIDE 25 mg/g

Identifiers & Regulatory

Product NDC 82429-313
Product ID 82429-313_10189f3f-e1ca-7b29-e063-6294a90affa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206164
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82429313
Hyphenated Format 82429-313

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 (82429-313-45) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

82429-313-45 1 BOTTLE, PUMP in 1 CARTON (82429-313-45) / 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": "10189f3f-e1ca-7b29-e063-6294a90affa7", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0382429313450"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539"], "spl_set_id": ["06862a25-6e7c-4633-b611-0836151218bd"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["GABAR HEALTH SCIENCES CORP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (82429-313-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "82429-313-45", "marketing_start_date": "20231127"}], "brand_name": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%", "product_id": "82429-313_10189f3f-e1ca-7b29-e063-6294a90affa7", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "82429-313", "generic_name": "Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%", "labeler_name": "GABAR HEALTH SCIENCES CORP", "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"}