Profilnine (factor ix complex) NDC 68516-3210

NDC codes

FDA NDC Directory

Product NDC (as listed)68516-3210Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68516-3210Add 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
68516-3210-1	68516321001	1 KIT in 1 CARTON (68516-3210-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, GLASS (76297-002-02)Marketed from Jul 20, 1981

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Profilnine
Generic name (nonproprietary): factor ix complex
Dosage form: Kit
Route: Intravenous
Labeler: GRIFOLS USA, LLC
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 102476
Marketing start: Jul 20, 1981
Listing expires: Dec 31, 2027
Identifiers: Product ID 68516-3210_d13b6d66-7106-4a34-8521-1cf16d2578b9SPL ID d13b6d66-7106-4a34-8521-1cf16d2578b9

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468516321001 followed by a unit qualifier and the quantity

Package 68516-3210-01. 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 102476

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

FDA NDC Directory listings under BLA 102476
Product	Strength	Form · route	Labeler	Product NDC
Profilninefactor ix complex	—	KitIntravenous	GRIFOLS USA, LLC	68516-3211
Profilninefactor ix complex	—	KitIntravenous	GRIFOLS USA, LLC	68516-3212