Stimufend (pegflilgrastim-fpgk) NDC 65219-371

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-371Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0371Add 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
65219-371-10	65219037110	1 BLISTER PACK in 1 CARTON (65219-371-10) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGEMarketed from Oct 6, 2022

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): Stimufend
Generic name (nonproprietary): pegflilgrastim-fpgk
Active ingredients: Pegfilgrastim — 6 mg/.6mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761173
Marketing start: Oct 6, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Granulocyte Colony-Stimulating Factor (Chemical structure)Granulocyte-Macrophage Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
Identifiers: Product ID 65219-371_90fa8a88-1bd6-49cf-a482-ccbc0d315b3dSPL ID 90fa8a88-1bd6-49cf-a482-ccbc0d315b3dSPL set ID b44bcb82-7e60-4dab-a658-115bdf5c053cRxCUI 2613763, 2613769UNII 3A58010674
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 codeMed-Code curated

J2506 — Injection, pegfilgrastim, excludes biosimilar, 0.5 mg

Billing unit: 0.5 mg. Units on the claim = dose given ÷ 0.5 mg.

Pegfilgrastim biosimilars have their own HCPCS codes.

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

N465219037110 followed by a unit qualifier and the quantity

Package 65219-0371-10. 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

Current FDA label (SPL), effective Oct 24, 2023.

Indications (excerpt from the label)

Stimufend is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend is indicated to decrease the …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761173

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

FDA NDC Directory listings under BLA 761173
Product	Strength	Form · route	Labeler	Product NDC
Stimufendpegflilgrastim-fpgk	Pegfilgrastim 6 mg/.6mL	Injection, SolutionSubcutaneous	NORTHSTAR RX LLC	72603-402