FDA.reportPublic FDA data

ENHERTU 100 MG Injection

RxCUI
2267581
RxNorm name
ENHERTU 100 MG Injection
Display name
ENHERTU 100 MG Injection
Full name
ENHERTU 100 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761139Enhertufam-trastuzumab deruxtecan-nxki351(a)Rx2026-09-01

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
EnhertuFAM-TRASTUZUMAB DERUXTECAN-NXKIDaiichi Sankyo Inc.7e67e73e-ddf4-4e4d-8b50-09d7514910b62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2267581

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
7e67e73e-ddf4-4e4d-8b50-09d7514910b6ENHERTU 100 MG Injection [PSN] · fam-trastuzumab deruxtecan-nxki 100 MG Injection [Enhertu] [SBD] · Enhertu 100 MG Injection [SY]328These highlights do not include all the information needed to use ENHERTU safely and effectively. See full prescribing information for ENHERTU. ENHERTU ® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U.S. Approval: 201920260515