FDA.reportPublic FDA data

Tyenne 400 MG in 20 ML Injection

RxCUI
2679443
RxNorm name
Tyenne 400 MG in 20 ML Injection
Display name
Tyenne 400 MG in 20 ML Injection
Full name
Tyenne 400 MG in 20 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761275Tyennetocilizumab-aazg351(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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYENNETOCILIZUMAB-AAZGFresenius Kabi USA, LLCe400bbe6-43c5-4de6-82b9-cb44ce3cd9062024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2679443

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
e400bbe6-43c5-4de6-82b9-cb44ce3cd906Tyenne 400 MG in 20 ML Injection [PSN] · 20 ML tocilizumab-aazg 20 MG/ML Injection [Tyenne] [SBD] · 20 ML Tyenne 20 MG/ML Injection [SY] · Tyenne 400 MG per 20 ML Injection [SY]42These highlights do not include all the information needed to use TYENNE safely and effectively. See full prescribing information for TYENNE. TYENNE ® (tocilizumab-aazg) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2024 TYENNE ® (tocilizumab-aazg) 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 d20241230