FDA.reportPublic FDA data

ado-trastuzumab emtansine 160 MG Injection

RxCUI
1658089
RxNorm name
ado-trastuzumab emtansine 160 MG Injection
Display name
ado-trastuzumab emtansine 160 MG Injection
Full name
ado-trastuzumab emtansine 160 MG Injection
Term type
SCD
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
125427Kadcylaado-trastuzumab emtansine351(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
KADCYLAADO-TRASTUZUMAB EMTANSINEGenentech, Inc.23f3c1f4-0fc8-4804-a9e3-04cf25dd302e2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1658089

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
23f3c1f4-0fc8-4804-a9e3-04cf25dd302eado-trastuzumab emtansine 160 MG Injection [PSN] · ado-trastuzumab emtansine 160 MG Injection [SCD]235These highlights do not include all the information needed to use KADCYLA safely and effectively. See full prescribing information for KADCYLA. KADCYLA ® (ado-trastuzumab emtansine) for injection, for intravenous use Initial U.S. Approval: 201320260401