opdivo qvantig

Generic: nivolumab and hyaluronidase-nvhy

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

Drug Facts

Product Profile

Brand Name opdivo qvantig
Generic Name nivolumab and hyaluronidase-nvhy
Labeler e.r. squibb & sons, l.l.c.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase (human recombinant) 2000 U/mL, nivolumab 120 mg/mL

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

Identifiers & Regulatory

Product NDC 0003-3120
Product ID 0003-3120_63db7271-4d46-45d1-99b9-18821495ea77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761381
Listing Expiration 2026-12-31
Marketing Start 2024-12-27

Pharmacologic Class

Established (EPC)
endoglycosidase [epc] programmed death receptor-1 blocking antibody [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00033120
Hyphenated Format 0003-3120

Supplemental Identifiers

RxCUI
2700798 2700805 2728491 2728492
UNII
743QUY4VD8 31YO63LBSN
NUI
N0000175531 M0009499 N0000191260 N0000191259

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 opdivo qvantig (source: ndc)
Generic Name nivolumab and hyaluronidase-nvhy (source: ndc)
Application Number BLA761381 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2000 U/mL
  • 120 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3120-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0003-3120-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3120-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

hyaluronidase (human recombinant) (2000 U/mL) nivolumab (120 mg/mL)

Linked Drug Pages (1)

OPDIVO QVANTIG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "63db7271-4d46-45d1-99b9-18821495ea77", "openfda": {"nui": ["N0000175531", "M0009499", "N0000191260", "N0000191259"], "unii": ["743QUY4VD8", "31YO63LBSN"], "rxcui": ["2700798", "2700805", "2728491", "2728492"], "spl_set_id": ["7f8c38fa-42f4-4387-9e8c-7a1c66855d8b"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]", "Programmed Death Receptor-1 Blocking Antibody [EPC]"], "pharm_class_moa": ["Programmed Death Receptor-1-directed Antibody Interactions [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 (0003-3120-01)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0003-3120-01", "marketing_start_date": "20251124"}], "brand_name": "OPDIVO QVANTIG", "product_id": "0003-3120_63db7271-4d46-45d1-99b9-18821495ea77", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]", "Programmed Death Receptor-1 Blocking Antibody [EPC]", "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "product_ndc": "0003-3120", "generic_name": "nivolumab and hyaluronidase-nvhy", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPDIVO QVANTIG", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "2000 U/mL"}, {"name": "NIVOLUMAB", "strength": "120 mg/mL"}], "application_number": "BLA761381", "marketing_category": "BLA", "marketing_start_date": "20241227", "listing_expiration_date": "20261231"}