Prescription medicine
Floxuridine First approved as Fudr
Floxuridine (Fudr) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the floxuridine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the NDA 16929 record on Drugs@FDA; every floxuridine label on DailyMed.
Highlights of the record
FDA label of October 14, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFloxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means.
Forms and strengths
- 500 mg
- 100 mg/ml
- 500 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 18, 1970 Fudr, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 6, 2000; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 165 through July 30, 2026
What is floxuridine used for?
From the label: indications and usageFloxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.
FDA pharmacologic class: Antimetabolite.
Source: FDA drug label (Floxuridine), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set c8edabc1-67cd-421b-a147-7c1f19f05b8e), via openFDA; the full label on DailyMed
Is there a generic for floxuridine (Fudr)?
The FDA approved the first generic floxuridine on April 6, 2000. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists floxuridine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 2000 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for floxuridine?
The FDA Adverse Event Reporting System holds 165 reports that list floxuridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 43 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimetabolites
- the pharmacologic class, with prices and generics
- Floxuridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other