FDA.reportPublic FDA data

Bkemv 300 MG per 30 ML Injection

RxCUI
2706358
RxNorm name
Bkemv 300 MG per 30 ML Injection
Display name
Bkemv 300 MG per 30 ML Injection
Full name
Bkemv 300 MG per 30 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761333Bkemveculizumab-aeeb351(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
BKEMVECULIZUMAB-AEEBAmgen Inc002f9748-b0e8-4b6e-a38b-56930a8394912026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2706358

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
002f9748-b0e8-4b6e-a38b-56930a839491Bkemv 300 MG per 30 ML InjectionSY7These highlights do not include all the information needed to use BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV ® (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) 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 between the b20251201
002f9748-b0e8-4b6e-a38b-56930a83949130 ML eculizumab-aeeb 10 MG/ML Injection [Bkemv]SBD7These highlights do not include all the information needed to use BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV ® (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) 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 between the b20251201
002f9748-b0e8-4b6e-a38b-56930a839491BKEMV 300 MG in 30 ML InjectionPSN7These highlights do not include all the information needed to use BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV ® (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) 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 between the b20251201