NDC Code(s) : 0003-7125-11
Packager : E.R. Squibb & Sons, L.L.C.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OPDUALAGnivolumab and relatlimab-rmbw INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-7125
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIVOLUMAB(UNII: 31YO63LBSN)
(NIVOLUMAB - UNII:31YO63LBSN) 		NIVOLUMAB12 mg in 1 mL
RELATLIMAB(UNII: AF75XOF6W3)
(RELATLIMAB - UNII:AF75XOF6W3) 		RELATLIMAB4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)1.1 mg in 1 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)2.7 mg in 1 mL
PENTETIC ACID(UNII: 7A314HQM0I)0.008 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)85.6 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0003-7125-111 in 1 CARTON 18/03/2022
120 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761234 03/18/2022

LABELER - E.R. Squibb & Sons, L.L.C.(011550092)

PRINCIPAL DISPLAY PANEL

NDC 0003-7125-11

Rx only

OpdualagTM

(nivolumab and relatlimab -rmbw)

Injection

240 mg and 80 mg/20 mL

(12 mg and 4 mg/mL)

For Intravenous Infusion Only

Single-dose vial; Discard unused portion.

Please provide enclosed Medication Guide to the patient.

Bristol Myers Squibb

opdualag-carton.jpg