Fluorouracil is a prescription medicine (Nucleoside Metabolic Inhibitor). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- Efudex, Tolak
- Drug class
- Nucleoside Metabolic Inhibitor
- Taken
- Topical
- Label
- Bausch Health US, LLC, revised April 23, 2025 · full label on DailyMed
- Generic
- FDA-approved (10 companies) · details
Is there a generic Fluorouracil?
Yes. The FDA has approved generic Fluorouracil from 10 companies whose approvals are active. The earliest of these was approved in 1998.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Accord Hlthcare, Alembic, Dr Reddys Labs Sa, Encube, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland, Kindos, Sagent Pharms Inc, Taro
Brand-name versions
- Adrucil Pharmacia And Upjohn Discontinued
- Efudex Extrovis, approved 1970
- Fluoroplex Elorac, approved 1970 Discontinued
- Carac Extrovis, approved 2000
- Tolak Hill Dermaceuticals, approved 2015
- Favlyxa Avyxa Holdings, approved 2026
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Fluorouracil in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 35de1c1c-bef5-46c5-b6f8-ea032147411c.