Active ingredient
Eculizumab
3 finished FDA listings contain Eculizumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ECULIZUMAB, ECULIZUMAB-AAGH
- Dosage forms
- Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 300 mg/30ml
- Brand names in FDA listings
- Bkemv, Epysqli, Soliris
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 591781
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 125166 | ALEXION PHARM | 2007-03-16 | 1 |
| BLA 761333 | AMGEN INC | 2024-05-28 | 1 |
| BLA 761340 | SAMSUNG BIOEPIS CO LTD | 2024-07-19 | 1 |
Official labeling on DailyMed
- EPYSQLI (ECULIZUMAB-AAGH) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] · version 5 · 2026-07-14
- BKEMV (ECULIZUMAB-AEEB) INJECTION, SOLUTION, CONCENTRATE [AMGEN INC] · version 8 · 2026-07-13
- SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.] · version 44 · 2026-07-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.