efudex

Generic: fluorouracil

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name efudex
Generic Name fluorouracil
Labeler bausch health us, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil 2 g/40g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-3204
Product ID 0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016831
Listing Expiration 2026-12-31
Marketing Start 1970-07-29

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01873204
Hyphenated Format 0187-3204

Supplemental Identifiers

RxCUI
105583 213045
UNII
U3P01618RT
NUI
N0000000233 N0000175595

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 efudex (source: ndc)
Generic Name fluorouracil (source: ndc)
Application Number NDA016831 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/40g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE
source: ndc

Packages (1)

0187-3204-47 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE

Ingredients (1)

fluorouracil (2 g/40g)

Linked Drug Pages (1)

Efudex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3375c5f7-9b6f-8ca1-e063-6394a90aaff8", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["105583", "213045"], "spl_set_id": ["35de1c1c-bef5-46c5-b6f8-ea032147411c"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0187-3204-47)  / 40 g in 1 TUBE", "package_ndc": "0187-3204-47", "marketing_end_date": "20260930", "marketing_start_date": "19700729"}], "brand_name": "Efudex", "product_id": "0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0187-3204", "generic_name": "Fluorouracil", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efudex", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "2 g/40g"}], "application_number": "NDA016831", "marketing_category": "NDA", "marketing_start_date": "19700729", "listing_expiration_date": "20261231"}