Quick answers
- What is Pegfilgrastim-cbqv used for?
- The FDA-approved label (Udenyca, Accord BioPharma, Inc., April 23, 2026) says: “UDENYCA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pegfilgrastim-cbqv have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pegfilgrastim-cbqv?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pegfilgrastim-cbqv been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 16, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Pegfilgrastim-cbqv?
- 10 companies list prescription products of Pegfilgrastim-cbqv in the FDA NDC Directory, including Accord BioPharma Inc., Coherus Oncology, Inc. and Amgen, Inc.
What Pegfilgrastim-cbqv is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
UDENYCA 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. …
— FDA label: Udenyca, Accord BioPharma, Inc., effective April 23, 2026. Read the full label on DailyMed →
The FDA has 9 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.
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 9 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 |
|---|---|---|
| pegfilgrastim 6 mg/0.6 mL injection | Brand: Fulphila | $3,362.78 per mL |
NADAC list of November 4, 2026; these prices took effect on 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.
- Accord BioPharma Inc.3 products
- Coherus Oncology, Inc.3 products
- Amgen, Inc2 products
- NorthStar Rx LLC1 product
- Pfizer Laboratories Div Pfizer Inc1 product
- Biocon Biologics Inc.1 product
- Sandoz Inc1 product
- Fresenius Kabi USA, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125031 NEULASTA | Amgen | January 31, 2002 | 29, latest August 4, 2026 2026: Labeling · 2025: Manufacturing (CMC) · 2021: Labeling |
| BLA761039 UDENYCA | Coherus Biosciences Inc | November 2, 2018 | 7, latest December 22, 2023 2023: Efficacy · 2023: Efficacy · 2022: Efficacy |
| BLA761045 ZIEXTENZO | Sandoz Inc | November 4, 2019 | 4, latest May 12, 2026 2026: Labeling · 2024: BIOSIMILAR · 2023: Manufacturing (CMC) |
| BLA761075 FULPHILA | Mylan GmbH | June 4, 2018 | 4, latest October 13, 2023 2023: Labeling · 2021: Labeling · 2019: Labeling |
| BLA761084 FYLNETRA | Kashiv Biosciences LLC | May 26, 2022 | 1, latest April 23, 2025 2025: BIOSIMILAR |
| BLA761111 NYVEPRIA | Hospira Inc | June 10, 2020 | 2, latest May 21, 2026 2026: Labeling · 2021: Labeling |
| BLA761173 STIMUFEND | Fresenius Kabi USA | September 1, 2022 | 3, latest October 21, 2025 2025: Labeling · 2025: Labeling · 2023: BIOSIMILAR |
| BLA761212 ARMLUPEG | Lupin Ltd | November 28, 2025 | — |
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.
-
January 16, 2026 · Class I · Ongoing · D-0353-2026
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 — McKesson
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) | 2048020, 2048025, 2102703, 2102705, 2260704, 2260709, 2469335, 2469340, 2602781, 2602787 … (+8) |
|---|---|
| SPL set ID of the quoted label | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 |
| FDA labels (SPL) | 9 |
| FDA applications | BLA125031, BLA761039, BLA761045, BLA761075, BLA761084, BLA761111, BLA761173, BLA761212 |
| Active ingredients (FDA) | PEGFILGRASTIM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Udenyca, Accord BioPharma, Inc., effective April 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 →