FDA.reportPublic FDA data

2 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]

RxCUI
2699122
RxNorm name
2 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]
Display name
2 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]
Full name
2 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761151Bimzelxbimekizumab-bkzx351(a)Rx2026-06-01

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
BimzelxBIMEKIZUMABUCB, Inc.26b88358-871f-4c80-9d80-b2fb16477f812025-06-16Warnings, Adverse reactionsExact identifier
rxcui: 2699122

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
26b88358-871f-4c80-9d80-b2fb16477f812 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]SBD14These highlights do not include all the information needed to use BIMZELX safely and effectively. See full prescribing information for BIMZELX. BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use Initial U.S. Approval: 202320250616
26b88358-871f-4c80-9d80-b2fb16477f81Bimzelx 320 MG per 2 ML Auto-InjectorSY14These highlights do not include all the information needed to use BIMZELX safely and effectively. See full prescribing information for BIMZELX. BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use Initial U.S. Approval: 202320250616
26b88358-871f-4c80-9d80-b2fb16477f81Bimzelx 320 MG in 2 ML Auto-InjectorPSN14These highlights do not include all the information needed to use BIMZELX safely and effectively. See full prescribing information for BIMZELX. BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use Initial U.S. Approval: 202320250616