Medicine
Ixinity kit
Ixinity kit is a prescription medicine containing Coagulation factor ix, marketed by Medexus Pharma, 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
Color Code Nominal Strength Kit NDC Number Yellow 250 IU 59137-287-05 Blue 500…
Key facts
- Active ingredient (INN)
- Coagulation factor ix
- Brand
- Ixinity
- Dosage form
- Kit
- Packs
- 1 kit and 1 more
- Marketing authorisation holder
- Medexus Pharma
- Manufacturer
- Medexus Pharma
- Origin register
- US FDA, United States
- Storage
- Color Code Nominal Strength Kit NDC Number Yellow 250 IU 59137-287-05 Blue 500 IU 59137-282-05 Green 1000 IU 59137-283-05 Orange 1500 IU 59137-284-05 Red 2000 IU 59137-288-05 Brown 3000 IU 59137-289-05 250 IU strength only, store at 2 to 8°C (36 to 46°F). 500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F). Do not freeze.
- 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
- 12 May 2017
- Identifiers
- RxCUI 1666311, 1666328DailyMed set ID 26bc221d-c9bc-4aba-92f3-6c21acaaf194NDC 59137-288, 59137-284, 59137-287 +3Application BLA125426
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 vial * 5 mL in 1 syringe | 59137-282-05 | Medexus Pharma | 1 July 2021 |
| 1 kit in 1 carton * 5 mL in 1 vial * 5 mL in 1 syringe | 59137-283-05 | Medexus Pharma | 1 July 2021 |
| 1 kit in 1 carton * 5 mL in 1 vial * 5 mL in 1 syringe | 59137-284-05 | Medexus Pharma | 1 July 2021 |
| 1 kit in 1 carton * 5 mL in 1 vial * 5 mL in 1 syringe | 59137-289-05 | Medexus Pharma | 1 July 2021 |
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 Ixinity 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.