Quick answers
- What is Releuko?
- Releuko is a brand name of Filgrastim, a prescription medicine. The FDA NDC Directory lists 4 Releuko products in 4 strengths and forms.
- Who makes Releuko?
- Kashiv Biosciences LLC holds the FDA application for Releuko (BLA761082, approved February 25, 2022).
- Is there a generic or store brand of Releuko?
- Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Releuko product. Ask your pharmacist whether one is right for you.
- Has Releuko been recalled?
- No recall linked to Releuko products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Releuko is
Each Releuko 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.
Filgrastim · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| filgrastim 300 ug/0.5 mL injection, solution (intravenous, subcutaneous) | Releuko | 5 products, 5 companies | DailyMed |
| filgrastim 300 ug/mL injection, solution (intravenous, subcutaneous) | Releuko | 3 products, 3 companies | DailyMed |
| filgrastim 480 ug/0.8 mL injection, solution (intravenous, subcutaneous) | Releuko | 5 products, 5 companies | DailyMed |
| filgrastim 480 ug/1.6 mL injection, solution (intravenous, subcutaneous) | Releuko | 3 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Filgrastim →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA761082 | Kashiv Biosciences LLC | February 25, 2022 | 4 |
Companies that list Releuko
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Releuko products.
- Amneal Pharmaceuticals LLC4 products
Recalls
No recall linked to Releuko products (by their NDC code or label) appears in the FDA enforcement reports.
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.