NDC 63323-562
Bivalirudin 250 mg injection, powder, lyophilized, for solution
On the label: Fresenius Kabi, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Product details
- Generic drug
- Bivalirudin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 250 mg
- Approval
- ANDA ANDA090189
- On the market since
- Oct 30, 2017
- Package NDCs
63323-562-1563323-562-41- Official label
- DailyMed (National Library of Medicine), updated Aug 27, 2025
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