FDA.reportPublic FDA data

30 ML eculizumab-aagh 10 MG/ML Injection

RxCUI
2706338
RxNorm name
30 ML eculizumab-aagh 10 MG/ML Injection
Display name
30 ML eculizumab-aagh 10 MG/ML Injection
Full name
30 ML eculizumab-aagh 10 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761340Epysqlieculizumab-aagh351(k) InterchangeableRx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPYSQLIECULIZUMAB-AAGHTeva Pharmaceuticals USA, Inc.1fa1aa80-1c59-44d4-9841-b6c52882651b2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2706338

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1fa1aa80-1c59-44d4-9841-b6c52882651b30 ML eculizumab-aagh 10 MG/ML InjectionSCD4These highlights do not include all the information needed to use EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI ® (eculizumab-aagh) injection, for intravenous use Initial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA approved biological product, known as a reference product, and that there are no clinically meaningful differences betwe20260415
1fa1aa80-1c59-44d4-9841-b6c52882651beculizumab-aagh 300 MG per 30 ML InjectionSY4These highlights do not include all the information needed to use EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI ® (eculizumab-aagh) injection, for intravenous use Initial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA approved biological product, known as a reference product, and that there are no clinically meaningful differences betwe20260415
1fa1aa80-1c59-44d4-9841-b6c52882651beculizumab-aagh 300 MG in 30 ML InjectionPSN4These highlights do not include all the information needed to use EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI ® (eculizumab-aagh) injection, for intravenous use Initial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA approved biological product, known as a reference product, and that there are no clinically meaningful differences betwe20260415