opdualag

Generic: nivolumab and relatlimab-rmbw

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name opdualag
Generic Name nivolumab and relatlimab-rmbw
Labeler e.r. squibb & sons, l.l.c.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nivolumab 12 mg/mL, relatlimab 4 mg/mL

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-7125
Product ID 0003-7125_1150d07b-4d33-4285-a242-1ecf12ed5a4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761234
Listing Expiration 2026-12-31
Marketing Start 2022-03-18

Pharmacologic Class

Established (EPC)
programmed death receptor-1 blocking antibody [epc] lymphocyte activation gene-3 blocker [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa] lymphocyte activation gene-3 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00037125
Hyphenated Format 0003-7125

Supplemental Identifiers

RxCUI
2596778 2596784
UNII
31YO63LBSN AF75XOF6W3
NUI
N0000191260 N0000191259 N0000194003 N0000194002

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name opdualag (source: ndc)
Generic Name nivolumab and relatlimab-rmbw (source: ndc)
Application Number BLA761234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12 mg/mL
  • 4 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0003-7125-11 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

nivolumab (12 mg/mL) relatlimab (4 mg/mL)

Linked Drug Pages (1)

OPDUALAG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1150d07b-4d33-4285-a242-1ecf12ed5a4c", "openfda": {"nui": ["N0000191260", "N0000191259", "N0000194003", "N0000194002"], "unii": ["31YO63LBSN", "AF75XOF6W3"], "rxcui": ["2596778", "2596784"], "spl_set_id": ["b22c9d83-3256-4e17-85f7-f331a504adc6"], "pharm_class_epc": ["Programmed Death Receptor-1 Blocking Antibody [EPC]", "Lymphocyte Activation Gene-3 Blocker [EPC]"], "pharm_class_moa": ["Programmed Death Receptor-1-directed Antibody Interactions [MoA]", "Lymphocyte Activation Gene-3 Antagonists [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0003-7125-11", "marketing_start_date": "20220318"}], "brand_name": "OPDUALAG", "product_id": "0003-7125_1150d07b-4d33-4285-a242-1ecf12ed5a4c", "dosage_form": "INJECTION", "pharm_class": ["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]"], "product_ndc": "0003-7125", "generic_name": "nivolumab and relatlimab-rmbw", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPDUALAG", "active_ingredients": [{"name": "NIVOLUMAB", "strength": "12 mg/mL"}, {"name": "RELATLIMAB", "strength": "4 mg/mL"}], "application_number": "BLA761234", "marketing_category": "BLA", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}