FDA.reportPublic FDA data

1 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx]

RxCUI
2668093
RxNorm name
1 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx]
Display name
1 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx]
Full name
1 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [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)Rx2026-08-01

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: 2668093

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
26b88358-871f-4c80-9d80-b2fb16477f81Bimzelx 160 MG in 1 ML Prefilled Syringe [PSN] · 1 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx] [SBD] · Bimzelx 160 MG per 1 ML Prefilled Syringe [SY]314These 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