twyneo

Generic: tretinoin and benzoyl peroxide

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

Drug Facts

Product Profile

Brand Name twyneo
Generic Name tretinoin and benzoyl peroxide
Labeler galderma laboratories, l.p.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzoyl peroxide 30 mg/g, tretinoin 1 mg/g

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5945
Product ID 0299-5945_c8da4970-d262-4f55-a092-0a469789eb1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214902
Marketing Start 2022-03-15
Marketing End 2026-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02995945
Hyphenated Format 0299-5945

Supplemental Identifiers

RxCUI
2565807 2565812
UNII
W9WZN9A0GM 5688UTC01R
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 twyneo (source: ndc)
Generic Name tretinoin and benzoyl peroxide (source: ndc)
Application Number NDA214902 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
  • 1 mg/g
source: ndc
Packaging
  • 6 g in 1 TUBE (0299-5945-00)
  • 30 g in 1 BOTTLE, PUMP (0299-5945-05)
  • 1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

0299-5945-00 6 g in 1 TUBE (0299-5945-00) 0299-5945-05 30 g in 1 BOTTLE, PUMP (0299-5945-05) 0299-5945-30 1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP

Ingredients (2)

benzoyl peroxide (30 mg/g) tretinoin (1 mg/g)

Linked Drug Pages (1)

TWYNEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c8da4970-d262-4f55-a092-0a469789eb1f", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["W9WZN9A0GM", "5688UTC01R"], "rxcui": ["2565807", "2565812"], "spl_set_id": ["27208dff-e376-4c18-b56e-0a260f685a39"], "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": "6 g in 1 TUBE (0299-5945-00)", "package_ndc": "0299-5945-00", "marketing_end_date": "20261031", "marketing_start_date": "20220315"}, {"sample": true, "description": "30 g in 1 BOTTLE, PUMP (0299-5945-05)", "package_ndc": "0299-5945-05", "marketing_end_date": "20261031", "marketing_start_date": "20230711"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 BOX (0299-5945-30)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5945-30", "marketing_end_date": "20261031", "marketing_start_date": "20220315"}], "brand_name": "TWYNEO", "product_id": "0299-5945_c8da4970-d262-4f55-a092-0a469789eb1f", "dosage_form": "CREAM", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0299-5945", "generic_name": "tretinoin and benzoyl peroxide", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TWYNEO", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "30 mg/g"}, {"name": "TRETINOIN", "strength": "1 mg/g"}], "application_number": "NDA214902", "marketing_category": "NDA", "marketing_end_date": "20261031", "marketing_start_date": "20220315"}