NDC codes

FDA NDC Directory
Product NDC (as listed)63459-918Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63459-0918Add 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 NDC11-digit (billing)PackageCopy
63459-918-596345909185910 VIAL in 1 CARTON (63459-918-59) / 1 mL in 1 VIAL (63459-918-53)Marketed from Nov 7, 2018

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/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125294
Marketing start
Listing expires
Other FDA classes
Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
Identifiers
Product ID 63459-918_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

N463459091859 followed by a unit qualifier and the quantity

Package 63459-0918-59. 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
ProductStrengthForm · routeLabelerProduct NDC
Granixtbo-filgrastimFilgrastim 300 ug/.5mLInjection, SolutionSubcutaneousCephalon, LLC63459-910
Granixtbo-filgrastimFilgrastim 480 ug/.8mLInjection, SolutionSubcutaneousCephalon, LLC63459-912
Granixtbo-filgrastimFilgrastim 480 ug/1.6mLInjection, SolutionSubcutaneousCephalon, LLC63459-920

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Granix (tbo-filgrastim) NDC 63459-918 | Med-Code