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 |
|---|
| HYALURONIDASE (HUMAN RECOMBINANT) | 2000 U/mL |
| NIVOLUMAB | 120 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31YO63LBSN, 743QUY4VD8 |
| Rxcui | 2700798, 2700805, 2728491, 2728492 |
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 |
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 |