Medicine
Bivalirudin 250 mg injection
Bivalirudin 250 mg injection is a generic prescription medicine for intravenous use, made by 2 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 Bivalirudin Injection vials in the refrigerator between 2° to 8°C (36°…
Key facts
- Active ingredient (INN)
- Bivalirudin
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial, 10 vials and 1 more
- Manufacturers
- MAIA PharmaceuticalsPar Health
- Origin register
- US FDA, United States
- Storage
- Store Bivalirudin Injection vials in the refrigerator between 2° to 8°C (36° to 46°F). Once removed from the refrigerator, Bivalirudin Injection may be stored at room temperature 20º to 25°C (68º to 77°F) for up to 72 hours).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AE06 Bivalirudin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 June 2023
- Identifiers
- RxCUI 1997015DailyMed set ID c727199d-f4cd-4658-8fdf-568590beface, 91cf9d00-29e0-4357-a184-f70026c47edbNDC 70511-142, 42023-622Application NDA211215
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 / 1 injection, solution in 1 vial, single-dose | 70511-142-50 | MAIA Pharmaceuticals | 27 May 2024 |
| 10 vial, single-dose in 1 carton / 1 injection, solution in 1 vial, single-dose | 70511-142-84 | MAIA Pharmaceuticals | 27 May 2024 |
| 1 vial, single-dose in 1 carton / 1 injection, solution in 1 vial, single-dose | 42023-622-01 | Par Health | 19 June 2023 |
| 10 vial, single-dose in 1 carton / 1 injection, solution in 1 vial, single-dose | 42023-622-10 | Par Health | 19 June 2023 |
| 10 vial, single-dose in 1 carton / 1 injection in 1 vial, single-dose | 55111-652-37 | — | 31 May 2017 |
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
Alternatives
Other makers and brands of Bivalirudin 250 mg injection.
Other strengths and forms of Bivalirudin
Clinical summary
Bivalirudin is an anti-coagulant indicated as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. MedsAcross supplies Bivalirudin 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 BivalirudinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- bivalirudin prescribing information (Civica) · U.S. National Library of Medicine, DailyMed
Need Bivalirudin 250 mg 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.