Prescription drug · BLA
Filkri (filgrastim-laha) NDC 69448-008
Filgrastim 300 ug/.5mL · Injection, Solution · Intravenous, Subcutaneous · Accord BioPharma Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69448-008-03 | 69448000803 | 10 SYRINGE in 1 BOX (69448-008-03) / .5 mL in 1 SYRINGEMarketed from Jul 15, 2026 | |
| 69448-008-63 | 69448000863 | 1 SYRINGE in 1 BOX (69448-008-63) / .5 mL in 1 SYRINGEMarketed from Jun 29, 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)
- Filkri
- Generic name (nonproprietary)
- filgrastim-laha
- Active ingredients
- Filgrastim — 300 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Accord BioPharma Inc.,
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761027
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 69448-008_6dd7213f-3c00-4539-9c76-96c904676827SPL ID 6dd7213f-3c00-4539-9c76-96c904676827SPL set ID 9c2f9573-08fd-43be-a489-8a5e5d8ab2ffRxCUI 2747351, 2747358, 2747360, 2747361UNII PVI5M0M1GWUPC 0369448009632, 0369448008635
- 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
N469448000803followed by a unit qualifier and the quantityPackage 69448-0008-03. 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)
FILKRI 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 (BMT)…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761027
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 |
|---|---|---|---|---|
| Filkrifilgrastim-laha | Filgrastim 480 ug/.8mL | Injection, SolutionIntravenous, Subcutaneous | Accord BioPharma Inc., | 69448-009 |