FDA.reportPublic FDA data

1 ML canakinumab 150 MG/ML Injection [Ilaris]

RxCUI
1864326
RxNorm name
1 ML canakinumab 150 MG/ML Injection [Ilaris]
Display name
1 ML canakinumab 150 MG/ML Injection [Ilaris]
Full name
1 ML canakinumab 150 MG/ML Injection [Ilaris]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125319Ilariscanakinumab351(a)Disc2026-08-01

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
IlarisCANAKINUMABNovartis Pharmaceuticals Corporation7d271f3b-e4f9-4d80-8dcf-28d49123f80e2026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 1864326

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
7d271f3b-e4f9-4d80-8dcf-28d49123f80eILARIS 150 MG in 1 ML Injection [PSN] · 1 ML canakinumab 150 MG/ML Injection [Ilaris] [SBD] · 1 ML Ilaris 150 MG/ML Injection [SY] · Ilaris 150 MG per 1 ML Injection [SY]430These highlights do not include all the information needed to use ILARIS safely and effectively. See full prescribing information for ILARIS. ILARIS ® (canakinumab) injection, for subcutaneous use Initial U.S. Approval: 200920250618