FDA.reportPublic FDA data

OPDUALAG

Product NDC
0003-7125
11-digit product format
000037125
Labeler code
0003
Product ID
0003-7125_1150d07b-4d33-4285-a242-1ecf12ed5a4c
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OPDUALAG
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31YO63LBSN, AF75XOF6W3
Rxcui2596778, 2596784

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

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