FDA.reportPublic FDA data

IMDELLTRA 10 MG Injection

RxCUI
2682971
RxNorm name
IMDELLTRA 10 MG Injection
Display name
IMDELLTRA 10 MG Injection
Full name
IMDELLTRA 10 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 10 MG Injection [PSN] · tarlatamab-dlle 10 MG Injection [Imdelltra] [SBD] · Imdelltra 10 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