ARTISS
- Product NDC
- 0944-8503
- 11-digit product format
- 009448503
- Labeler code
- 0944
- Product ID
- 0944-8503_d24dc76a-fdfd-45cc-be76-310843afb46d
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Fibrinogen Human Thrombin Human
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Baxalta US Inc.
- Application
- BLA125266
- Marketing category
- BLA
- Marketing start
- 2009-03-19
- Marketing end
- 2019-06-30
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 90 mg/mL; [iU]/mL
- Pharmacologic 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
- 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 | 0944-8503 | D | Discontinued by firm | 2026-07-31 | ||
| excluded product | product | 0944-8503 | D | Discontinued by firm | 2026-07-31 | ||
| excluded product | product | 0944-8503 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0944-8503 | 0944-8503-10 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8503 | 0944-8503-04 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0944-8503 | 0944-8503-02 | D | Discontinued by firm | 2026-07-31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0944-8503-02 | ML - Milliliter | 0944-8503 | 966372ba-72ad-4756-9809-381ac3beb69a | 1 | 2013-02-11 |
| 0944-8503-04 | ML - Milliliter | 0944-8503 | 368d2ff9-3557-4dd1-aade-5c54afe3ff90 | 1 | 2013-02-11 |
| 0944-8503-10 | ML - Milliliter | 0944-8503 | 465af0f9-acee-4181-8cb5-2fbf66f70ddc | 1 | 2012-07-24 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | Rx | 2026-06-01 |