FDA.reportPublic FDA data

Tysabri 300 MG per 15 ML Injection

RxCUI
603541
RxNorm name
Tysabri 300 MG per 15 ML Injection
Display name
Tysabri 300 MG per 15 ML Injection
Full name
Tysabri 300 MG per 15 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125104Tysabrinatalizumab351(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
TYSABRINATALIZUMABBiogen Inc.c5fdde91-1989-4dd2-9129-4f3323ea29622025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 603541

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
c5fdde91-1989-4dd2-9129-4f3323ea2962Tysabri 300 MG in 15 ML Injection [PSN] · 15 ML natalizumab 20 MG/ML Injection [Tysabri] [SBD] · 15 ML Tysabri 20 MG/ML Injection [SY] · Tysabri 300 MG per 15 ML Injection [SY]447These highlights do not include all the information needed to use TYSABRI safely and effectively. See full prescribing information for TYSABRI. TYSABRI (natalizumab) injection, for intravenous use Initial U.S. Approval: 200420250321