| NDC Code | 0944-8402-01 |
| Package Description | 1 SYRINGE, PLASTIC in 1 POUCH (0944-8402-01) > 2 mL in 1 SYRINGE, PLASTIC (0944-8402-02) |
| Product NDC | 0944-8402 |
| Product Type Name | PLASMA DERIVATIVE |
| Proprietary Name | Tisseel |
| Proprietary Name Suffix | Frozen |
| Non-Proprietary Name | Fibrinogen Human And Thrombin Human |
| Dosage Form | SOLUTION |
| Usage | TOPICAL |
| Start Marketing Date | 19980501 |
| End Marketing Date | 20190731 |
| Marketing Category Name | BLA |
| Application Number | BLA103980 |
| Manufacturer | Baxalta US Inc. |
| Substance Name | FIBRINOGEN HUMAN; HUMAN THROMBIN |
| Strength | 90; 500 |
| Strength Unit | [iU]/mL; [iU]/mL |
| Pharmacy Classes | Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS] |