BeneFIX (coagulation factor ix (recombinant)) NDC 58394-636

NDC codes

FDA NDC Directory

Product NDC (as listed)58394-636Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58394-0636Add 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
58394-636-03	58394063603	1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03)Marketed from Jul 6, 2007

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): BeneFIX
Generic name (nonproprietary): coagulation factor ix (recombinant)
Dosage form: Kit
Labeler: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103677
Marketing start: Jul 6, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 58394-636_3b0657cb-0070-4c64-b72c-2518178805e7SPL ID 3b0657cb-0070-4c64-b72c-2518178805e7

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N458394063603 followed by a unit qualifier and the quantity

Package 58394-0636-03. 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 103677

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

FDA NDC Directory listings under BLA 103677
Product	Strength	Form · route	Labeler	Product NDC
BeneFIXcoagulation factor ix (recombinant)	—	Kit	Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC	58394-634
BeneFIXcoagulation factor ix (recombinant)	—	Kit	Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC	58394-633
BeneFIXcoagulation factor ix (recombinant)	—	Kit	Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC	58394-635
BeneFIXcoagulation factor ix (recombinant)	—	Kit	Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC	58394-637