FDA.reportPublic FDA data

20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]

RxCUI
2596784
RxNorm name
20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]
Display name
20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]
Full name
20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761234Opdualagnivolumab and relatlimab-rmbw351(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
OPDUALAGNIVOLUMAB AND RELATLIMAB-RMBWE.R. Squibb & Sons, L.L.C.b22c9d83-3256-4e17-85f7-f331a504adc62026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 2596784

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
b22c9d83-3256-4e17-85f7-f331a504adc6Opdualag 240 MG / 80 MG in 20 ML Injection [PSN] · 20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag] [SBD] · Opdualag (nivolumab-rmbw 240 MG / relatlimab-rmbw 80 MG) per 20 ML Injection [SY]32These highlights do not include all the information needed to use OPDUALAG safely and effectively. See full prescribing information for OPDUALAG. OPDUALAG™ (nivolumab and relatlimab-rmbw) injection, for intravenous use Initial U.S. Approval: 202220240301