Home Applications 125166 Application 125166
Type BLA
Sponsor ALEXION PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125166 Soliris eculizumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOLIRIS ECULIZUMAB INJECTABLE; IV (INFUSION) 300MG No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125166 ndc (product): 25682-001
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. BLA Current 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. BLA Current 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. BLA Current 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals I BLA Current 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. BLA Current 25682-001 SOLIRIS ECULIZUMAB Alexion Pharmaceuticals Inc. BLA Current