Prescription drug · BLA
Nivestym (filgrastim-aafi) NDC 0069-0294
Filgrastim 480 ug/1.6mL · Injection, Solution · Intravenous, Subcutaneous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0294-10 | 00069029410 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) / 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)Marketed from Mar 11, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nivestym
- Generic name (nonproprietary)
- filgrastim-aafi
- Active ingredients
- Filgrastim — 480 ug/1.6mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761080
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 0069-0294_e73179c2-1306-443c-a5ed-d2748e96147cSPL ID e73179c2-1306-443c-a5ed-d2748e96147cSPL set ID d23ab39c-b6ec-41cf-a529-9dd2852c9d9aRxCUI 2057200, 2057205, 2057209, 2057212, 2057215, 2057216, 2057218, 2057219UNII 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
N400069029410followed by a unit qualifier and the quantityPackage 00069-0294-10. 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 .
Indications (excerpt from the label)
NIVESTYM 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 transplanta…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761080
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 |
|---|---|---|---|---|
| Nivestymfilgrastim-aafi | Filgrastim 480 ug/.8mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0292 |
| Nivestymfilgrastim-aafi | Filgrastim 300 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0293 |
| Nivestymfilgrastim-aafi | Filgrastim 300 ug/.5mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0291 |