| NDC Code | 83634-400-10 |
|---|
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41) |
|---|
| Product NDC | 83634-400 |
|---|
| 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 | 20231218 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA210031 |
|---|
| Manufacturer | Avenacy, Inc. |
|---|
| Substance Name | BIVALIRUDIN |
|---|
| Strength | 250 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
|---|