Active ingredient
Floxuridine
3 finished FDA listings contain Floxuridine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLOXURIDINE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intra-Arterial
- Manufacturers / labelers
- 3
- Strengths listed
- 100 mg/ml · 500 mg/1 · 500 mg/5ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4488
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075387 | HIKMA | 2000-04-06 | 2 |
| ANDA 075837 | FRESENIUS KABI USA | 2001-02-22 | 1 |
Official labeling on DailyMed
- FLOXURIDINE (FLOXURIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 4 · 2024-10-21
- FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JND THERAPEUTICS, INC.] · version 7 · 2024-10-09
- FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2023-05-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.