Quick answers
- What is Udenyca?
- Udenyca is a brand name of Pegfilgrastim-cbqv, a prescription medicine. The FDA NDC Directory lists 6 Udenyca products in 1 strength and form.
- Who makes Udenyca?
- Coherus Biosciences Inc holds the FDA application for Udenyca (BLA761039, approved November 2, 2018). 1 other company (repackagers or distributors) also list Udenyca products.
- Is there a generic or store brand of Udenyca?
- Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Udenyca product. Ask your pharmacist whether one is right for you.
- Has Udenyca been recalled?
- FDA enforcement reports list 1 recall of Udenyca products; the newest started January 16, 2026. A recall usually concerns specific lots, not every product.
What Udenyca is
Each Udenyca product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Pegfilgrastim-cbqv · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pegfilgrastim 6 mg/0.6 mL injection, solution (subcutaneous) | Udenyca | 3 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pegfilgrastim-cbqv →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA761039 | Coherus Biosciences Inc | November 2, 2018 | 6 |
Companies that list Udenyca
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Udenyca products.
- Accord BioPharma, Inc.3 products
- Coherus Oncology, Inc.3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.