Alexion Pharmaceuticals Inc.
NDC labeler code: 25682
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Asfotase alfaStrensiq · 4 products
- RavulizumabUltomiris · 3 products
- DanicopanVoydeya · 1 product
- Eculizumab-aaghEpysqli, Soliris, Bkemv · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 29, 2024 | NDA218037 | Danicopan VOYDEYA | Alexion Pharms Inc |
| December 21, 2018 | BLA761108 | Ravulizumab ULTOMIRIS | Alexion Pharm |
| October 23, 2015 | BLA125513 | Asfotase alfa STRENSIQ | Alexion Pharm |
| March 16, 2007 | BLA125166 | Eculizumab-aagh SOLIRIS | Alexion Pharm |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2014
-
June 2, 2014 · Class I · Terminated · D-1512-2014 · Eculizumab-aagh
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
2013
-
November 4, 2013 · Class I · Terminated · D-1049-2014 · Eculizumab-aagh
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC
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).
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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026