NDC 71288-427
BIVALIRUDIN
Bivalirudin
BIVALIRUDIN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Bivalirudin.
| Product ID | 71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7 |
| NDC | 71288-427 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BIVALIRUDIN |
| Generic Name | Bivalirudin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-07-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091602 |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Substance Name | BIVALIRUDIN |
| Active Ingredient Strength | 250 mg/5mL |
| Pharm Classes | Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |