Prescription drug · BLA
Zarxio (filgrastim-sndz) NDC 61314-318
Filgrastim 300 ug/.5mL · Injection, Solution · Intravenous, Subcutaneous · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-318-01 | 61314031801 | 1 BLISTER PACK in 1 CARTON (61314-318-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGEMarketed from Feb 22, 2018 | |
| 61314-318-10 | 61314031810 | 2 BLISTER PACK in 1 CARTON (61314-318-10) / 5 SYRINGE in 1 BLISTER PACK (61314-318-05) / .5 mL in 1 SYRINGEMarketed from Feb 22, 2018 | |
| 61314-318-63 | 61314031863 | 1 BLISTER PACK in 1 CARTON (61314-318-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGEMarketed from Jun 12, 2026 | |
| 61314-318-69 | 61314031869 | 2 BLISTER PACK in 1 CARTON (61314-318-69) / 5 SYRINGE in 1 BLISTER PACK (61314-318-65) / .5 mL in 1 SYRINGEMarketed from Jun 12, 2026 |
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)
- Zarxio
- Generic name (nonproprietary)
- filgrastim-sndz
- Active ingredients
- Filgrastim — 300 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125553
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 61314-318_f213544a-940c-4fd3-b769-d227ff6b76d0SPL ID f213544a-940c-4fd3-b769-d227ff6b76d0SPL set ID c0d1c22b-566b-4776-bdbf-00f96dad0caeRxCUI 1605066, 1605071, 1605074, 1605075UNII PVI5M0M1GW
- 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.
- NDC on a medical claim
N461314031801followed by a unit qualifier and the quantityPackage 61314-0318-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ZARXIO is a leukocyte growth factor indicated to • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125553
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zarxiofilgrastim-sndz | Filgrastim 480 ug/.8mL | Injection, SolutionIntravenous, Subcutaneous | Sandoz Inc. | 61314-326 |