Xarelto kit is a prescription medicine containing Rivaroxaban, marketed by Janssen Pharmaceuticals, 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
Store at room temperature between 20 °C to 25 °C (68 °F to 77 °F), excursions…
Key facts
- Active ingredient (INN)
- Rivaroxaban
- Brand
- Xarelto
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Janssen Pharmaceuticals
- Manufacturer
- Janssen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Do not freeze the granules or reconstituted suspension.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AF01 Rivaroxaban
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 September 2014
- Identifiers
- RxCUI 1114198, 1114202, 1232082 +7DailyMed set ID 10db92f9-2300-4a80-836b-673e1ae91610NDC 50458-584Application NDA022406
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 * 42 tablet, film coated in 1 blister pack * 9 tablet, film coated in 1 blister pack | 50458-584-51 | Janssen Pharmaceuticals | 16 September 2014 |
| 1 kit in 1 carton * 42 tablet, film coated in 1 blister pack * 9 tablet, film coated in 1 blister pack | 50458-584-52 | Janssen Pharmaceuticals | 1 November 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.
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 Rivaroxaban
Clinical summary
Rivaroxaban is a factor Xa inhibitor. It is available as tablets, oral suspension and kits. MedsAcross supplies Rivaroxaban 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 RivaroxabanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xarelto prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Xarelto: European public assessment report (EPAR) · European Medicines Agency
- Rivaroxaban Accord: European public assessment report (EPAR) · European Medicines Agency
Need Xarelto 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.