FDA.reportPublic FDA data

20 ML tocilizumab-bavi 20 MG/ML Injection

RxCUI
2680296
RxNorm name
20 ML tocilizumab-bavi 20 MG/ML Injection
Display name
20 ML tocilizumab-bavi 20 MG/ML Injection
Full name
20 ML tocilizumab-bavi 20 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761354Tofidencetocilizumab-bavi351(k) BiosimilarRx2026-07-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOFIDENCETOCILIZUMABOrganon LLC1ab3207a-ebfe-4565-9ce5-3a1538815c832026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2680296
TofidenceTOCILIZUMABBiogen MA Inc00529b23-850a-42b9-a152-125a95b5242c2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2680296

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00529b23-850a-42b9-a152-125a95b5242ctocilizumab-bavi 400 MG in 20 ML Injection [PSN] · 20 ML tocilizumab-bavi 20 MG/ML Injection [SCD] · tocilizumab-bavi 400 MG per 20 ML Injection [SY]310These highlights do not include all the information needed to use TOFIDENCE safely and effectively. See full prescribing information for TOFIDENCE. TOFIDENCE™ (tocilizumab-bavi) injection, for intravenous use Initial U.S. Approval: 2023 TOFIDENCE (tocilizumab-bavi) is biosimilar 1 to ACTEMRA (tocilizumab). 1 - Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are n20251219
1ab3207a-ebfe-4565-9ce5-3a1538815c83tocilizumab-bavi 400 MG in 20 ML Injection [PSN] · 20 ML tocilizumab-bavi 20 MG/ML Injection [SCD] · tocilizumab-bavi 400 MG per 20 ML Injection [SY]32These highlights do not include all the information needed to use TOFIDENCE safely and effectively. See full prescribing information for TOFIDENCE. TOFIDENCE ® (tocilizumab-bavi) injection, for intravenous use Initial U.S. Approval: 2023 TOFIDENCE (tocilizumab-bavi) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe20250922