Quick answers
- What is Filgrastim used for?
- The FDA-approved label (Neupogen, Amgen, Inc, July 23, 2026) says: “NEUPOGEN 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 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Filgrastim have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Filgrastim?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Filgrastim been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started February 27, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Filgrastim?
- 8 companies list prescription products of Filgrastim in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc, Amneal Pharmaceuticals LLC and Amgen, Inc.
What Filgrastim is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEUPOGEN 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 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of …
— FDA label: Neupogen, Amgen, Inc, effective July 23, 2026. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| filgrastim 300 ug/0.5 mL injection, solution | Brand: Neupogen | $650.05 per mL |
| filgrastim 300 ug/0.5 mL injection, solution | Brand: Zarxio | $531.66 per mL |
| filgrastim 300 ug/mL injection, solution | Brand: Neupogen | $304.09 per mL |
| filgrastim 480 ug/0.8 mL injection, solution | Brand: Zarxio | $533.41 per mL |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pfizer Laboratories Div Pfizer Inc4 products
- Amneal Pharmaceuticals LLC4 products
- Amgen, Inc4 products
- Cephalon, LLC4 products
- Sandoz Inc2 products
- Cipla USA Inc.2 products
- Accord BioPharma Inc.2 products
- Tanvex BioPharma USA, Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103353 NEUPOGEN | Amgen | February 20, 1991 | 23, latest July 16, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| BLA125294 GRANIX | Sicor Biotech | August 29, 2012 | 8, latest November 21, 2023 2023: Labeling · 2019: Labeling · 2019: Labeling |
| BLA125553 ZARXIO | Sandoz Inc | March 6, 2015 | 9, latest August 21, 2025 2025: BIOSIMILAR · 2025: Manufacturing (CMC) · 2024: Labeling |
| BLA761027 FILKRI | Accord Biopharma Inc. | January 15, 2026 | — |
| BLA761080 NIVESTYM | Hospira Inc | July 20, 2018 | 3, latest February 16, 2024 2024: Labeling · 2023: Labeling · 2021: Labeling |
| BLA761082 RELEUKO | Kashiv Biosciences LLC | February 25, 2022 | 3, latest April 29, 2025 2025: BIOSIMILAR · 2023: BIOSIMILAR · 2022: Labeling |
| BLA761126 NYPOZI | Tanvex Biopharma USA Inc | June 28, 2024 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 27, 2025 · Class II · Ongoing · D-0285-2025
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial — Amgen, Inc.
-
February 27, 2025 · Class II · Ongoing · D-0286-2025
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC — Amgen, Inc.
-
January 10, 2025 · Class II · Ongoing · D-0218-2025
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC — Teva Pharmaceuticals USA, Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 727535, 727537, 727544, 727545, 1605066, 1605071, 1605074, 1605075, 1649944, 1649946 … (+10) |
|---|---|
| SPL set ID of the quoted label | 97cc73cc-b5b7-458a-a933-77b00523e193 |
| FDA labels (SPL) | 7 |
| FDA applications | BLA103353, BLA125294, BLA125553, BLA761027, BLA761080, BLA761082, BLA761126 |
| Active ingredients (FDA) | FILGRASTIM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Neupogen, Amgen, Inc, effective July 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →