NDC 0944-8402
TISSEEL Frozen
Fibrinogen Human And Thrombin Human
TISSEEL Frozen is a Topical Solution in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is Fibrinogen Human; Human Thrombin.
| Product ID | 0944-8402_3d62a922-847e-4810-9045-a83d3b967ea2 |
| NDC | 0944-8402 |
| Product Type | Plasma Derivative |
| Proprietary Name | TISSEEL Frozen |
| Generic Name | Fibrinogen Human And Thrombin Human |
| Dosage Form | Solution |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2011-02-18 |
| Marketing End Date | 2019-07-31 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103980 |
| Labeler Name | Baxalta US Inc. |
| Substance Name | FIBRINOGEN HUMAN; HUMAN THROMBIN |
| Active Ingredient Strength | 90 [iU]/mL; [iU]/mL |
| Pharm Classes | Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [CS] |
| NDC Exclude Flag | N |
Packaging
NDC 0944-8402-10
1 SYRINGE, PLASTIC in 1 CARTON (0944-8402-10) > 10 mL in 1 SYRINGE, PLASTIC
| Marketing Start Date | 2011-02-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0944-8402-10 [00944840210]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
NDC 0944-8402-09 [00944840209]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
NDC 0944-8402-03 [00944840203]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
NDC 0944-8402-02 [00944840202]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
NDC 0944-8402-01 [00944840201]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
NDC 0944-8402-04 [00944840204]
TISSEEL Frozen SOLUTION
| Marketing Category | BLA |
| Application Number | BLA103980 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1998-05-01 |
| Marketing End Date | 2019-07-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FIBRINOGEN HUMAN | 90 [iU]/mL |
Pharmacological Class
- Human Blood Coagulation Factor [EPC]
- Increased Coagulation Activity [PE]
- Blood Coagulation Factors [CS]
- Human Blood Coagulation Factor [EPC]
- Increased Coagulation Factor Activity [PE]
- Blood Coagulation Factors [CS]
NDC Crossover Matching brand name "TISSEEL Frozen" or generic name "Fibrinogen Human And Thrombin Human"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63713-390 | EVICEL Fibrin Sealant (Human) | Fibrinogen Human and Thrombin Human |
| 0944-8402 | TISSEEL | fibrinogen human and thrombin human |
Trademark Results [TISSEEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSEEL 73373730 1286760 Live/Registered |
Immuno, Aktiengesellschaft fur Chemischmedizinische Produkte 1982-07-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.