| NDC Code | 63323-562-10 |
| Package Description | 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
| Product NDC | 63323-562 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Bivalirudin |
| Non-Proprietary Name | Bivalirudin |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20161028 |
| Marketing Category Name | ANDA |
| Application Number | ANDA090189 |
| Manufacturer | Fresenius Kabi USA, LLC |
| Substance Name | BIVALIRUDIN |
| Strength | 250 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |