FDA.reportPublic FDA data

1 ML talquetamab-tgvs 40 MG/ML Injection

RxCUI
2644461
RxNorm name
1 ML talquetamab-tgvs 40 MG/ML Injection
Display name
1 ML talquetamab-tgvs 40 MG/ML Injection
Full name
1 ML talquetamab-tgvs 40 MG/ML Injection
Term type
SCD
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)Rx2026-08-01

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: 2644461

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
9001355e-003d-4d4e-b4ce-337e0fd14952talquetamab-tgvs 40 MG in 1 ML Injection [PSN] · 1 ML talquetamab-tgvs 40 MG/ML Injection [SCD] · talquetamab-tgvs 40 MG per 1 ML Injection [SY]35These 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