NDC codes

FDA NDC Directory
Product NDC (as listed)61314-866Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61314-0866Add 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
61314-866-02613140866021 BLISTER PACK in 1 CARTON (61314-866-02) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGEMarketed from Mar 3, 2025

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)
Ziextenzo
Generic name (nonproprietary)
pegfilgrastim-bmez
Active ingredients
Pegfilgrastim — 6 mg/.6mL
Dosage form
Injection
Route
Subcutaneous
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761045
Marketing start
Listing expires
Other FDA classes
Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
Identifiers
Product ID 61314-866_1e0e90a7-6205-4ed2-b315-4b884da070a3SPL ID 1e0e90a7-6205-4ed2-b315-4b884da070a3SPL set ID 7dada041-6528-4acf-809c-62d271538c9aRxCUI 2260704, 2260709UNII 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

N461314086602 followed by a unit qualifier and the quantity

Package 61314-0866-02. 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 .

Indications (excerpt from the label)

ZIEXTENZO 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 ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO is indicated in adults an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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