epiduo forte

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

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

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5906
Product ID 0299-5906_253bb988-14bf-4654-e063-6394a90a0fe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207917
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02995906
Hyphenated Format 0299-5906

Supplemental Identifiers

RxCUI
1663745 1663747
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 forte (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
  • 2 g in 1 TUBE (0299-5906-00)
  • 1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE
  • 1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP
source: ndc

Packages (8)

0299-5906-00 2 g in 1 TUBE (0299-5906-00) 0299-5906-02 1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE 0299-5906-05 1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE 0299-5906-15 1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP 0299-5906-30 1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP 0299-5906-45 1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP 0299-5906-60 1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP 0299-5906-70 1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP

Ingredients (2)

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

Linked Drug Pages (1)

epiduo forte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "253bb988-14bf-4654-e063-6394a90a0fe0", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM"], "rxcui": ["1663745", "1663747"], "spl_set_id": ["f4e5d381-098a-4c93-9ff0-002cae46daac"], "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": "2 g in 1 TUBE (0299-5906-00)", "package_ndc": "0299-5906-00", "marketing_start_date": "20191101"}, {"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-5906-02)  / 2 g in 1 TUBE", "package_ndc": "0299-5906-02", "marketing_start_date": "20150701"}, {"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-5906-05)  / 5 g in 1 TUBE", "package_ndc": "0299-5906-05", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-15)  / 15 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5906-15", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-30)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5906-30", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5906-45", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-60)  / 60 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5906-60", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5906-70)  / 70 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5906-70", "marketing_start_date": "20150701"}], "brand_name": "epiduo forte", "product_id": "0299-5906_253bb988-14bf-4654-e063-6394a90a0fe0", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0299-5906", "generic_name": "adapalene and benzoyl peroxide", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "epiduo forte", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}], "application_number": "NDA207917", "marketing_category": "NDA", "marketing_start_date": "20150701", "listing_expiration_date": "20261231"}