FDA.reportPublic FDA data

emicizumab-kxwh 30 MG in 1 ML Injection

RxCUI
1989799
RxNorm name
emicizumab-kxwh 30 MG in 1 ML Injection
Display name
emicizumab-kxwh 30 MG in 1 ML Injection
Full name
emicizumab-kxwh 30 MG in 1 ML Injection
Term type
PSN
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
761083Hemlibraemicizumab-kxwh351(a)Rx2026-07-01

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
HemlibraEMICIZUMABGenentech, Inc.2483adba-fab6-4d1b-96c5-c195577ed0712025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1989799

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
2483adba-fab6-4d1b-96c5-c195577ed071emicizumab-kxwh 30 MG in 1 ML Injection [PSN] · 1 ML emicizumab-kxwh 30 MG/ML Injection [SCD] · emicizumab-kxwh 30 MG per 1 ML Injection [SY]317These highlights do not include all the information needed to use HEMLIBRA safely and effectively. See full prescribing information for HEMLIBRA. HEMLIBRA ® (emicizumab-kxwh) injection, for subcutaneous use Initial U.S. Approval: 201720250711