Medicine
Floxuridine 100 mg/mL powder for injection
Floxuridine 100 mg/mL powder for injection is a generic prescription medicine for intra-arterial use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
The sterile powder should be stored at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Floxuridine
- Brand
- Sold under the generic name
- Strength
- 100 mg/mL
- Dosage form
- Powder for injection
- Route
- Intra-arterial
- Packs
- 1 vial
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- The sterile powder should be stored at 20° to 25°C (68° to 77°F). Reconstituted vials should be stored under refrigeration 2° to 8°C (36° to 46°F) for not more than 2 weeks.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC09 Floxuridine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 March 2001
- Identifiers
- RxCUI 310351DailyMed set ID e3c2e3e7-bc83-465d-b615-3ad56580b3a7, c8edabc1-67cd-421b-a147-7c1f19f05b8eNDC 0143-9270, 63323-145Application ANDA075387, ANDA075837
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 5 mL in 1 vial | 63323-145-07 | Fresenius Kabi | 15 March 2001 |
| 1 vial in 1 box, unit-dose / 5 mL in 1 vial | 0143-9270-01 | Hikma Pharmaceuticals | 15 February 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 18 December 1970 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Floxuridine
Clinical summary
Floxuridine is an antimetabolite. It is available as powder for injection for intra-arterial use. MedsAcross supplies Floxuridine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FloxuridineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Floxuridine prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Floxuridine 100 mg/mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.