Plasma derivative · BLA
ARTISS Fibrin Sealant (Fibrinogen human, human thrombin) NDC 0338-9641
Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL · Solution · Topical · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9641-01 | 00338964101 | 10 mL in 1 SYRINGE, PLASTIC (0338-9641-01)Marketed from Mar 19, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ARTISS Fibrin SealantSuffix: Fibrin Sealant
- Generic name (nonproprietary)
- fibrinogen human, human thrombin
- Active ingredients
- Fibrinogen human — 86.5 mg/mLHuman thrombin — 4 [iU]/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125266
- Marketing start
- Listing expires
- Other FDA classes
- Blood Coagulation Factors (Chemical structure)Blood Coagulation Factors (Chemical structure)Increased Coagulation Activity (Physiologic effect)Increased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 0338-9641_7d6efeb5-5e06-4fd1-a04f-38af0483b6f2SPL ID 7d6efeb5-5e06-4fd1-a04f-38af0483b6f2
- Pharmacologic class
- Human Blood Coagulation Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400338964101followed by a unit qualifier and the quantityPackage 00338-9641-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0338-9641
- What is NDC 0338-9641?
- 0338-9641 is the product NDC for ARTISS Fibrin Sealant, Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ARTISS Fibrin Sealant (Fibrinogen Human, Human Thrombin).
- What is the active ingredient?
- Fibrinogen human, Human thrombin.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ARTISS Fibrin Sealant?
- 2 other product NDCs are listed under this name. See all ARTISS Fibrin Sealant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ARTISS Fibrin Sealant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ARTISS Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9637 | 00338-9637-01 |
| ARTISS Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9639 | 00338-9639-01 |
Other NDCs under BLA 125266
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ARTISS Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9637 |
| ARTISS Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9639 |