| NDC Code | 71288-427-92 |
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| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91) |
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| Product NDC | 71288-427 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Bivalirudin |
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| Non-Proprietary Name | Bivalirudin |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20180716 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA091602 |
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| Manufacturer | Meitheal Pharmaceuticals Inc. |
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| Substance Name | BIVALIRUDIN |
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| Strength | 250 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
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