ARTISS
- Product NDC
- 0338-9641
- 11-digit product format
- 003389641
- Labeler code
- 0338
- Product ID
- 0338-9641_7d6efeb5-5e06-4fd1-a04f-38af0483b6f2
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Fibrinogen Human, Human Thrombin
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Baxter Healthcare Corporation
- Application
- BLA125266
- Marketing category
- BLA
- Marketing start
- 2008-03-19
- Substance
- FIBRINOGEN HUMAN; HUMAN THROMBIN
- Active strength
- 86.5; 4 mg/mL; [iU]/mL
- Pharmacologic classes
- Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| N94833051K | FIBRINOGEN HUMAN | 9001-32-5 | FIBRINOGEN HUMAN |
| 6K15ABL77G | HUMAN THROMBIN | 9002-04-4 | HUMAN THROMBIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0338-9641-01 | 00338964101 | 10 mL in 1 SYRINGE, PLASTIC (0338-9641-01) | 10 ml | 2008-03-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ARTISS Fibrin Sealant | Baxter Healthcare Corporation | 2025-09-30 | PLASMA DERIVATIVE | 12 |
| ARTISS Fibrin Sealant | Baxter Healthcare Corporation | Takeda Manufacturing Austria AG | 2022-06-09 | PLASMA DERIVATIVE | 10 |