Medicine
Bivalirudin 250 mg powder for injectable suspension
Bivalirudin 250 mg powder for injectable suspension is a generic prescription medicine for intravenous use, 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 bivalirudin for injection dosage units at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Bivalirudin
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Powder for injectable suspension
- Route
- Intravenous
- Packs
- 1 injection, 10 injection
- Manufacturer
- Slate Run Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store bivalirudin for injection dosage units at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- 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
- 30 June 2021
- Identifiers
- RxCUI 308769DailyMed set ID 5d9a45c6-e234-4d56-9132-5e24e65852e6NDC 70436-025Application ANDA213078
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 injection, powder, lyophilized, for suspension in 1 vial, single-dose | 70436-025-80 | Slate Run Pharmaceuticals | 30 June 2021 |
| 10 injection, powder, lyophilized, for suspension in 1 carton | 70436-025-82 | Slate Run Pharmaceuticals | 30 June 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.
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 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 powder for injectable suspension 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.