FDA.reportPublic FDA data

IMDELLTRA 1 MG Injection

RxCUI
2682967
RxNorm name
IMDELLTRA 1 MG Injection
Display name
IMDELLTRA 1 MG Injection
Full name
IMDELLTRA 1 MG 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
761344Imdelltratarlatamab-dlle351(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.

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
1e7b6163-5d83-42ea-82c9-cf7620cdc782IMDELLTRA 1 MG Injection [PSN] · tarlatamab-dlle 1 MG Injection [Imdelltra] [SBD] · Imdelltra 1 MG Injection [SY]35These highlights do not include all the information needed to use IMDELLTRA ® safely and effectively. See full prescribing information for IMDELLTRA. IMDELLTRA ® (tarlatamab-dlle) for injection, for intravenous use Initial U.S. Approval: 202420251119