FDA.reportPublic FDA data

OPDUALAG

Product NDC
0003-7125
Requested package NDC
0003-7125-11
11-digit product format
000037125
Labeler code
0003
Product ID
0003-7125_7c285448-d5b9-4eca-b117-0d791b1b4de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nivolumab and relatlimab-rmbw
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
E.R. Squibb & Sons, L.L.C.
Application
BLA761234
Marketing category
BLA
Marketing start
2022-03-18
Substance
NIVOLUMAB; RELATLIMAB
Active strength
12; 4 mg/mL; mg/mL
Pharmacologic classes
Lymphocyte Activation Gene-3 Antagonists [MoA], Lymphocyte Activation Gene-3 Blocker [EPC], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
OPDUALAG
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIVOLUMAB12 mg/mL
RELATLIMAB4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31YO63LBSNInternal UNII lookup
AF75XOF6W3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2596778Internal RxNorm lookup
2596784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b22c9d83-3256-4e17-85f7-f331a504adc6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
cc8aeb65-d09e-4803-a7f6-91602fc46900Product name120230103
d9ed9875-2de0-480e-b03d-305aab8310a6Product name220160211
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-7125-11OPDUALAG1 in 1 CARTONINJECTION12
0003-7125-11OPDUALAG20 mL in 1 VIAL, SINGLE-DOSEINJECTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-7125-11ML - Milliliter0003-71255d2d7962-49ab-4426-9c59-83d0744eca6d12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-7125OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW) INJECTION [E.R. SQUIBB & SONS, L.L.C.]2Current NDC, Legacy NDC, 2 package rows20240307_b22c9d83-3256-4e17-85f7-f331a504adc6.zip

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
application number: BLA761234
ndc (package): 0003-7125-11
ndc (product): 0003-7125
ndc11 (package): 00003712511

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761234Opdualagnivolumab and relatlimab-rmbw351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2596778nivolumab-relatlimab-rmbw 240 MG / 80 MG in 20 ML InjectionPSNb22c9d83-3256-4e17-85f7-f331a504adc62
2596784Opdualag 240 MG / 80 MG in 20 ML InjectionPSNb22c9d83-3256-4e17-85f7-f331a504adc62
259678420 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]SBDb22c9d83-3256-4e17-85f7-f331a504adc62
259677820 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML InjectionSCDb22c9d83-3256-4e17-85f7-f331a504adc62
2596778nivolumab-relatlimab-rmbw 240 MG / 80 MG per 20 ML InjectionSYb22c9d83-3256-4e17-85f7-f331a504adc62
2596784Opdualag (nivolumab-rmbw 240 MG / relatlimab-rmbw 80 MG) per 20 ML InjectionSYb22c9d83-3256-4e17-85f7-f331a504adc62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-7125-11000037125111 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSE2022-03-180000-00-00NoNoCurrent