FDA.reportPublic FDA data

10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]

RxCUI
1719777
RxNorm name
10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]
Display name
10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]
Full name
10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OnivydeIRINOTECAN HYDROCHLORIDEIpsen Biopharmaceuticals, Inc.c8b58efa-1820-48a4-b70d-62918fc4abfc2025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719777

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
c8b58efa-1820-48a4-b70d-62918fc4abfcOnivyde 43 MG in 10 ML Injection [PSN] · 10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde] [SBD] · 10 ML Onivyde 4.3 MG/ML Injection [SY] · Onivyde 43 MG per 10 ML Injection [SY]49These highlights do not include all the information needed to use ONIVYDE safely and effectively. See full prescribing information for ONIVYDE ONIVYDE® (irinotecan liposome injection), for intravenous use Initial U.S. Approval: 199620250303