ARTISS Fibrin Sealant NDC 0338-9637

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9637Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9637Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0338-9637-01	00338963701	2 mL in 1 SYRINGE, PLASTIC (0338-9637-01)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 Corporation
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125266
Marketing start: Mar 19, 2008
Listing expires: Dec 31, 2027
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 0338-9637_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

N400338963701 followed by a unit qualifier and the quantity

Package 00338-9637-01. 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.

Other NDCs under BLA 125266

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125266
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	0338-9639
ARTISS Fibrin Sealantfibrinogen human, human thrombin	Fibrinogen human 86.5 mg/mL; Human thrombin 4 [iU]/mL	SolutionTopical	Baxter Healthcare Corporation	0338-9641