Medicine
BeneFIX kit
BeneFIX kit is a prescription medicine containing Coagulation factor ix, marketed by Wyeth BioPharma, 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 BeneFIX at room temperature or under refrigeration, at a temperature of…
Key facts
- Active ingredient (INN)
- Coagulation factor ix
- Brand
- BeneFIX
- Dosage form
- Kit
- Packs
- 1 kit and 2 more
- Marketing authorisation holder
- Wyeth BioPharma
- Manufacturer
- Wyeth BioPharma
- Origin register
- US FDA, United States
- Storage
- Store BeneFIX at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F). • Do not freeze to prevent damage to the diluent syringe. • Do not use BeneFIX after the expiration date on the label.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 February 1997
- Identifiers
- RxCUI 797544, 1666311, 1666317DailyMed set ID 85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4NDC 58394-633, 58394-636, 58394-634 +2Application BLA103677
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 carton * 5 mL in 1 syringe * 1 mL in 1 packet * 5 mL in 1 vial, single-use | 58394-633-03 | Wyeth BioPharma | 1 February 1997 |
| 1 kit in 1 carton * 5 mL in 1 syringe * 1 mL in 1 packet * 5 mL in 1 vial, single-use | 58394-634-03 | Wyeth BioPharma | 1 February 1997 |
| 1 kit in 1 carton * 5 mL in 1 syringe * 1 mL in 1 packet * 5 mL in 1 vial, single-use | 58394-635-03 | Wyeth BioPharma | 1 February 1997 |
| 1 kit in 1 carton * 5 mL in 1 syringe * 1 mL in 1 packet * 5 mL in 1 vial, single-use | 58394-636-03 | Wyeth BioPharma | 6 July 2007 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 syringe * 1 mL in 1 packet | 58394-637-03 | Wyeth BioPharma | 1 February 2012 |
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 |
| 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
Alternatives
Other makers and brands of Coagulation factor ix kit.
Clinical summary
Coagulation factor ix is a prescription medicine. It is available as kits for intravenous use. MedsAcross supplies Coagulation factor ix 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 Coagulation factor ixFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RIXUBIS prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need BeneFIX kit 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.