FDA.reportPublic FDA data

talquetamab-tgvs 3 MG per 1.5 ML Injection

RxCUI
2644452
RxNorm name
talquetamab-tgvs 3 MG per 1.5 ML Injection
Display name
talquetamab-tgvs 3 MG per 1.5 ML Injection
Full name
talquetamab-tgvs 3 MG per 1.5 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761342Talveytalquetamab-tgvs351(a)Rx2026-06-01

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
TALVEYTALQUETAMABJanssen Biotech, Inc.9001355e-003d-4d4e-b4ce-337e0fd149522025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2644452

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9001355e-003d-4d4e-b4ce-337e0fd14952talquetamab-tgvs 3 MG per 1.5 ML InjectionSY5These highlights do not include all the information needed to use TALVEY safely and effectively. See full prescribing information for TALVEY. TALVEY ® (talquetamab-tgvs) injection, for subcutaneous use Initial U.S. Approval: 202320251008
9001355e-003d-4d4e-b4ce-337e0fd14952talquetamab-tgvs 3 MG in 1.5 ML InjectionPSN5These highlights do not include all the information needed to use TALVEY safely and effectively. See full prescribing information for TALVEY. TALVEY ® (talquetamab-tgvs) injection, for subcutaneous use Initial U.S. Approval: 202320251008
9001355e-003d-4d4e-b4ce-337e0fd149521.5 ML talquetamab-tgvs 2 MG/ML InjectionSCD5These highlights do not include all the information needed to use TALVEY safely and effectively. See full prescribing information for TALVEY. TALVEY ® (talquetamab-tgvs) injection, for subcutaneous use Initial U.S. Approval: 202320251008