Home NDC 0003-6120 OPDIVO QVANTIG
Product NDC 0003-6120
11-digit product format 000036120
Labeler code 0003
Product ID 0003-6120_63db7271-4d46-45d1-99b9-18821495ea77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nivolumab and hyaluronidase-nvhy
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler E.R. Squibb & Sons, L.L.C.
Application BLA761381
Marketing category BLA
Marketing start 2025-01-02
Substance HYALURONIDASE (HUMAN RECOMBINANT); NIVOLUMAB
Active strength 2000; 120 U/mL; mg/mL
Pharmacologic classes Endoglycosidase [EPC], Glycoside Hydrolases [CS], 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 OPDIVO QVANTIG
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIVOLUMAB 120 mg/mL HYALURONIDASE (HUMAN RECOMBINANT) 2000 U/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 743QUY4VD8 Internal UNII lookup 31YO63LBSN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2700798 Internal RxNorm lookup 2700805 Internal RxNorm lookup 2728491 Internal RxNorm lookup 2728492 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0003-6120-01 OPDIVO QVANTIG 1 in 1 CARTON INJECTION, SOLUTION 1 8 0003-6120-01 OPDIVO QVANTIG 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-6120 OPDIVO QVANTIG (NIVOLUMAB AND HYALURONIDASE-NVHY) INJECTION, SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 3 Current NDC, 2 package rows 20250102_7f8c38fa-42f4-4387-9e8c-7a1c66855d8b.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761381 Opdivo Qvantig nivolumab and hyaluronidase-nvhy 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2728491 nivolumab-hyaluronidase-nvhy 300 MG / 5,000 UNT in 2.5 ML Injection PSN 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700798 nivolumab-hyaluronidase-nvhy 600 MG / 10,000 UNT in 5 ML Injection PSN 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2728492 OPDIVO Qvantig 300 MG / 5,000 UNT in 2.5 ML Injection PSN 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700805 OPDIVO Qvantig 600 MG / 10,000 UNT in 5 ML Injection PSN 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2728492 2.5 ML hyaluronidase-nvhy 2000 UNT/ML / nivolumab-nvhy 120 MG/ML Injection [Opdivo Qvantig] SBD 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700805 5 ML hyaluronidase-nvhy 2000 UNT/ML / nivolumab-nvhy 120 MG/ML Injection [Opdivo Qvantig] SBD 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2728491 2.5 ML hyaluronidase-nvhy 2000 UNT/ML / nivolumab-nvhy 120 MG/ML Injection SCD 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700798 5 ML hyaluronidase-nvhy 2000 UNT/ML / nivolumab-nvhy 120 MG/ML Injection SCD 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2728491 nivolumab-hyaluronidase-nvhy 300 MG / 5,000 UNT per 2.5 ML Injection SY 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700798 nivolumab-hyaluronidase-nvhy 600 MG / 10,000 UNT per 5 ML Injection SY 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2728492 Opdivo Qvantig (nivolumab-hyaluronidase-nvhy 300 MG / 5,000 UNT) per 2.5 ML Injection SY 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8 2700805 Opdivo Qvantig (nivolumab-hyaluronidase-nvhy 600 MG / 10,000 UNT) per 5 ML Injection SY 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0003-6120-01 00003612001 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-6120-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-01-02 No No Current