FDA.reportPublic FDA data

nivolumab 100 MG in 10 ML Injection

RxCUI
1657195
RxNorm name
nivolumab 100 MG in 10 ML Injection
Display name
nivolumab 100 MG in 10 ML Injection
Full name
nivolumab 100 MG in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125554Opdivonivolumab351(a)Rx2026-07-01

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
OPDIVONIVOLUMABE.R. Squibb & Sons, L.L.C.f570b9c4-6846-4de2-abfa-4d0a4ae4e3942026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 1657195

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
f570b9c4-6846-4de2-abfa-4d0a4ae4e394nivolumab 100 MG in 10 ML Injection [PSN] · 10 ML nivolumab 10 MG/ML Injection [SCD] · nivolumab 100 MG per 10 ML Injection [SY]367These highlights do not include all the information needed to use OPDIVO safely and effectively. See full prescribing information for OPDIVO. OPDIVO ® (nivolumab) injection, for intravenous use Initial U.S. Approval: 201420260512