Medicine
Fludarabine 50 mg/2 mL injection
Fludarabine 50 mg/2 mL injection is a generic prescription medicine for intravenous use, made by 5 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store in a refrigerator between 2˚ and 8˚C (36˚ to 46˚F).
Key facts
- Active ingredient (INN)
- Fludarabine
- Brand
- Sold under the generic name
- Strength
- 50 mg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 2 mL and 2 more
- Manufacturers
- Areva PharmaceuticalsFresenius KabiHisun PharmaceuticalsLannettSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator between 2˚ and 8˚C (36˚ to 46˚F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 November 2007
- Identifiers
- RxCUI 1740865DailyMed set ID 291f6ee2-f5d2-ae6c-e063-6294a90a5951, cf5255cc-91fd-4132-973b-764dba142eae, 8039c2e3-ffe5-3997-e053-2991aa0ad9d0 +2NDC 42658-024, 63323-192, 59923-604 +2Application ANDA220196, ANDA078393, ANDA090724 +1
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, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 59923-604-02 | Areva Pharmaceuticals | 31 December 2019 |
| 1 vial in 1 box / 2 mL in 1 vial | 63323-192-02 | Fresenius Kabi | 16 November 2007 |
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 42658-024-01 | Hisun Pharmaceuticals | 1 September 2026 |
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0527-1242-02 | Lannett | 31 December 2019 |
| 1 vial in 1 carton / 2 mL in 1 vial | 25021-242-02 | Sagent Pharmaceuticals | 15 October 2016 |
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 April 1991 | 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 Fludarabine
Clinical summary
Fludarabine is a nucleoside metabolic inhibitor indicated as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL), for the treatment of adults with B-cell CLL, among other approved uses. MedsAcross supplies Fludarabine 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 FludarabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fludarabine Phosphate prescribing information (Hisun Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fludarabine 50 mg/2 mL 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.