FDA.reportPublic FDA data

3 ML Tecvayli 10 MG/ML Injection

RxCUI
2619438
RxNorm name
3 ML Tecvayli 10 MG/ML Injection
Display name
3 ML Tecvayli 10 MG/ML Injection
Full name
3 ML Tecvayli 10 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761291Tecvayliteclistamab-cqyv351(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
TECVAYLITECLISTAMAB-CQYVJanssen Biotech, Inc.54e0f974-ccee-44ea-9254-40e9883cee1e2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2619438

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
54e0f974-ccee-44ea-9254-40e9883cee1e3 ML Tecvayli 10 MG/ML InjectionSY16These highlights do not include all the information needed to use TECVAYLI safely and effectively. See full prescribing information for TECVAYLI. TECVAYLI ® (teclistamab-cqyv) injection, for subcutaneous use Initial U.S. Approval: 202220260310
54e0f974-ccee-44ea-9254-40e9883cee1e3 ML teclistamab-cqyv 10 MG/ML Injection [Tecvayli]SBD16These highlights do not include all the information needed to use TECVAYLI safely and effectively. See full prescribing information for TECVAYLI. TECVAYLI ® (teclistamab-cqyv) injection, for subcutaneous use Initial U.S. Approval: 202220260310
54e0f974-ccee-44ea-9254-40e9883cee1eTecvayli 30 MG per 3 ML InjectionSY16These highlights do not include all the information needed to use TECVAYLI safely and effectively. See full prescribing information for TECVAYLI. TECVAYLI ® (teclistamab-cqyv) injection, for subcutaneous use Initial U.S. Approval: 202220260310
54e0f974-ccee-44ea-9254-40e9883cee1eTECVAYLI 30 MG in 3 ML InjectionPSN16These highlights do not include all the information needed to use TECVAYLI safely and effectively. See full prescribing information for TECVAYLI. TECVAYLI ® (teclistamab-cqyv) injection, for subcutaneous use Initial U.S. Approval: 202220260310