TISSEEL
- Product NDC
- 0944-8402
- 11-digit product format
- 009448402
- Labeler code
- 0944
- Product ID
- 0944-8402_daa6603b-825b-4e7d-8a5f-71d3a20d72a9
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- fibrinogen human and thrombin human
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Baxalta US Inc.
- Application
- BLA103980
- Marketing category
- BLA
- Marketing start
- 1998-05-01
- Marketing end
- 2019-07-31
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 90 [iU]/mL; [iU]/mL
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0944-8402 | D | Discontinued by firm | 2026-07-31 | ||
| excluded product | product | 0944-8402 | D | Discontinued by firm | 2026-07-31 | ||
| excluded product | product | 0944-8402 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0944-8402 | 0944-8402-10 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-03 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-09 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-03 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8402 | 0944-8402-09 | D | Discontinued by firm | 2026-07-31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0944-8402-02 | ML - Milliliter | 0944-8402 | 937cd5c7-2b9f-4db6-8ae4-f2a58d36c044 | 1 | 2012-07-24 |
| 0944-8402-04 | ML - Milliliter | 0944-8402 | b31d1a9a-26ed-42b3-ae74-b2286fff4c62 | 1 | 2012-07-24 |
| 0944-8402-10 | ML - Milliliter | 0944-8402 | 4672fa10-aa89-4dd4-a97f-970303ce9847 | 1 | 2012-07-24 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103980 | Tisseel | Fibrin Sealant (Tisseel) | 351(a) | Rx | 2026-06-01 |