FDA.reportPublic FDA data

ustekinumab-kfce 45 MG in 0.5 ML Injection

RxCUI
2705601
RxNorm name
ustekinumab-kfce 45 MG in 0.5 ML Injection
Display name
ustekinumab-kfce 45 MG in 0.5 ML Injection
Full name
ustekinumab-kfce 45 MG in 0.5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761406Yesintekustekinumab-kfce351(k) InterchangeableRx2026-07-01

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
YESINTEKUSTEKINUMABBiocon Biologics Inc.12a75613-ee33-d30a-215b-2a51cfa19b002026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 2705601

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
12a75613-ee33-d30a-215b-2a51cfa19b00ustekinumab-kfce 45 MG in 0.5 ML Injection [PSN] · 0.5 ML ustekinumab-kfce 90 MG/ML Injection [SCD] · ustekinumab-kfce 45 MG per 0.5 ML Injection [SY]39These highlights do not include all the information needed to use YESINTEK safely and effectively. See full prescribing information for YESINTEK. YESINTEK TM (ustekinumab-kfce) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 YESINTEK TM (ustekinumab-kfce) is biosimilar* to STELARA ® (ustekinumab).20251209