FDA.reportPublic FDA data

trastuzumab-pkrb 150 MG Injection [Herzuma]

RxCUI
2169362
RxNorm name
trastuzumab-pkrb 150 MG Injection [Herzuma]
Display name
trastuzumab-pkrb 150 MG Injection [Herzuma]
Full name
trastuzumab-pkrb 150 MG Injection [Herzuma]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761091Herzumatrastuzumab-pkrb351(k) BiosimilarRx2026-08-01

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
HERZUMATRASTUZUMABCephalon, Inc.ae71c003-883a-4cd8-ad50-e8cc9a54e9712025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2169362

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
ae71c003-883a-4cd8-ad50-e8cc9a54e971Herzuma 150 MG Injection [PSN] · trastuzumab-pkrb 150 MG Injection [Herzuma] [SBD] · Herzuma 150 MG Injection [SY]314These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA ® (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) 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 differences20251222