epiduo

Generic: adapalene and benzoyl peroxide

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epiduo
Generic Name adapalene and benzoyl peroxide
Labeler galderma laboratories, l.p.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5908
Product ID 0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022320
Listing Expiration 2026-12-31
Marketing Start 2008-12-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02995908
Hyphenated Format 0299-5908

Supplemental Identifiers

RxCUI
829539 830648
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 epiduo (source: ndc)
Generic Name adapalene and benzoyl peroxide (source: ndc)
Application Number NDA022320 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE
  • 2 g in 1 TUBE (0299-5908-02)
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP
  • 1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE
source: ndc

Packages (4)

0299-5908-00 1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE 0299-5908-02 2 g in 1 TUBE (0299-5908-02) 0299-5908-25 1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP 0299-5908-45 1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE

Ingredients (2)

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

Linked Drug Pages (1)

EPIDUO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "253bbb0c-966a-0d65-e063-6294a90a5f07", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["829539", "830648"], "spl_set_id": ["a0610f87-3b39-458a-afa3-66be1fefd1de"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-5908-00)  / 2 g in 1 TUBE", "package_ndc": "0299-5908-00", "marketing_start_date": "20081208"}, {"sample": true, "description": "2 g in 1 TUBE (0299-5908-02)", "package_ndc": "0299-5908-02", "marketing_start_date": "20081208"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5908-25)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5908-25", "marketing_start_date": "20081208"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0299-5908-45)  / 45 g in 1 TUBE", "package_ndc": "0299-5908-45", "marketing_start_date": "20081208"}], "brand_name": "EPIDUO", "product_id": "0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0299-5908", "generic_name": "adapalene and benzoyl peroxide", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPIDUO", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "NDA022320", "marketing_category": "NDA", "marketing_start_date": "20081208", "listing_expiration_date": "20261231"}