Kcentra kit is a prescription medicine containing Prothrombin and Water, marketed by CSL Behring, 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
Do not freeze. Do not freeze. Store KCENTRA between 2–25°C (36–77°F), this…
Key facts
- Active ingredient (INN)
- Prothrombin and Water
- Brand
- Kcentra
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- CSL Behring
- Manufacturer
- CSL Behring
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Do not freeze. Store KCENTRA between 2–25°C (36–77°F), this includes room temperature, not to exceed 25°C (77°F). If cooled, the solution should be warmed to 20–25°C prior to administration. Store the vial in the original carton to protect it from light. Reconstituted KCENTRA can be stored at 2–25°C.
- Cold chain
- Not required on record
- 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
- 29 April 2013
- Identifiers
- RxCUI 1484958, 1484963DailyMed set ID eee1afb8-324c-42e4-8bf0-f0c9da5e6d42NDC 63833-386, 63833-387Application BLA125421
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 * 20 mL in 1 vial, single-use * 20 mL in 1 vial, single-use | 63833-386-02 | CSL Behring | 29 April 2013 |
| 1 kit in 1 carton * 40 mL in 1 vial, single-use * 40 mL in 1 vial, single-use | 63833-387-02 | CSL Behring | 13 December 2013 |
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
Clinical summary
Prothrombin and Water is a fixed-dose combination medicine. It is available as kits. MedsAcross supplies Prothrombin and Water 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 Prothrombin and WaterFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Kcentra prescribing information (CSL Behring) · U.S. National Library of Medicine, DailyMed
Need Kcentra 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.