Medicine
Bivalirudin 250 mg powder for injection
Bivalirudin 250 mg powder for injection is a generic prescription medicine for intravenous use, made by 6 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.
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 injection
- Route
- Intravenous
- Packs
- 10 vials and 4 more
- Manufacturers
- EugiaIndiaFresenius KabiAvenacyCivicaHainan Shuangcheng PharmaceuticalsSandoz
- Origin register
- US FDA, United States
- Storage
- Store Bivalirudin for Injection dosage units at 20 to 25°C (68 to 77°F). Excursions to 15 to 30°C permitted.
- 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
- 15 June 2015
- Identifiers
- RxCUI 308769DailyMed set ID 61de12ff-e280-4bab-9804-43869ec45fa7, 42aa2630-83d6-433d-8277-0f672cf8d71d, ce56f806-7845-429d-a1ce-c2dbf79b22eb +4NDC 52958-034, 83634-400, 0781-3158 +3Application ANDA210031, NDA020873, ANDA090189 +1
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 55150-210-10 | EugiaIndia | 27 July 2018 |
| 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 63323-562-10 | Fresenius Kabi | 28 October 2016 |
| 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 63323-562-15 | Fresenius Kabi | 30 October 2017 |
| 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 52958-034-01 | Hainan Shuangcheng Pharmaceuticals | 23 October 2019 |
| 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 0781-3158-95 | Sandoz | 15 June 2015 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 83634-400-10 | Avenacy | 18 December 2023 |
| 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use | 72572-035-10 | Civica | 21 December 2020 |
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 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.