FDA.reportPublic FDA data

TYRUKO 300 MG in 15 ML Injection

RxCUI
2725180
RxNorm name
TYRUKO 300 MG in 15 ML Injection
Display name
TYRUKO 300 MG in 15 ML Injection
Full name
TYRUKO 300 MG in 15 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761322Tyrukonatalizumab-sztn351(k) BiosimilarRx2026-08-01

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
TYRUKONATALIZUMAB-SZTNSandoz Incef653c36-dd4b-4e71-9d2d-40b8fea24b672025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2725180

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
ef653c36-dd4b-4e71-9d2d-40b8fea24b67TYRUKO 300 MG in 15 ML Injection [PSN] · 15 ML natalizumab-sztn 20 MG/ML Injection [Tyruko] [SBD] · Tyruko 300 MG per 15 ML Injection [SY]313These highlights do not include all the information needed to use TYRUKO ® safely and effectively. See full prescribing information for TYRUKO . TYRUKO (natalizumab-sztn) injection, for intravenous use Initial U.S. Approval: 2023 TYRUKO (natalizumab-sztn) is biosimilar* to TYSABRI ® (natalizumab).20251031