Granix (tbo-filgrastim) NDC 63459-910

NDC codes

FDA NDC Directory

Product NDC (as listed)63459-910Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63459-0910Add 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
63459-910-11	63459091011	1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01)Marketed from Nov 11, 2013
63459-910-15	63459091015	10 BLISTER PACK in 1 CARTON (63459-910-15) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01)Marketed from Nov 11, 2013
63459-910-17	63459091017	1 SYRINGE, GLASS in 1 CARTON (63459-910-17) / .5 mL in 1 SYRINGE, GLASS (63459-910-18)Marketed from Mar 2, 2015
63459-910-36	63459091036	5 SYRINGE, GLASS in 1 CARTON (63459-910-36) / .5 mL in 1 SYRINGE, GLASS (63459-910-18)Marketed from Mar 2, 2015

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): Granix
Generic name (nonproprietary): tbo-filgrastim
Active ingredients: Filgrastim — 300 ug/.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Cephalon, LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125294
Marketing start: Nov 11, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
Identifiers: Product ID 63459-910_bebf458b-946a-4cc0-b565-5e2637f48cb2SPL ID bebf458b-946a-4cc0-b565-5e2637f48cb2
Pharmacologic class: Leukocyte Growth 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 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

N463459091011 followed by a unit qualifier and the quantity

Package 63459-0910-11. 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 125294

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

FDA NDC Directory listings under BLA 125294
Product	Strength	Form · route	Labeler	Product NDC
Granixtbo-filgrastim	Filgrastim 480 ug/.8mL	Injection, SolutionSubcutaneous	Cephalon, LLC	63459-912
Granixtbo-filgrastim	Filgrastim 300 ug/mL	Injection, SolutionSubcutaneous	Cephalon, LLC	63459-918
Granixtbo-filgrastim	Filgrastim 480 ug/1.6mL	Injection, SolutionSubcutaneous	Cephalon, LLC	63459-920