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Prescription medicine · generic available

Floxuridine

Drug class: Antimetabolite

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
3Companies
2000First FDA approval on file

Quick answers

What is Floxuridine used for?
The FDA-approved label (Floxuridine, Fresenius Kabi USA, LLC, October 14, 2024) says: “Floxuridine 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Floxuridine have a boxed warning?
The label we quote has no boxed warning, but 2 of 3 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Floxuridine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Floxuridine been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Floxuridine?
3 companies list prescription products of Floxuridine in the FDA NDC Directory, including Fresenius Kabi USA, LLC, JND Therapeutics, Inc. and Hikma Pharmaceuticals USA Inc..

What Floxuridine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Floxuridine 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. …

— FDA label: Floxuridine, Fresenius Kabi USA, LLC, effective October 14, 2024. Read the full label on DailyMed →

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

2 of 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, powder, lyophilized, for solution
RouteIntra-arterial
Prescription products3 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (2)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)310351
SPL set ID of the quoted labelc8edabc1-67cd-421b-a147-7c1f19f05b8e
FDA labels (SPL)3
FDA applications2 ANDA
Active ingredients (FDA)FLOXURIDINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Floxuridine, Fresenius Kabi USA, LLC, effective October 14, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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