Prescription drug · BLA
Opdivo Qvantig (Nivolumab and hyaluronidase-nvhy) NDC 0003-6120
Nivolumab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL · Injection, Solution · Subcutaneous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-6120-01 | 0000361200100003612001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-6120-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 2, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Opdivo Qvantig
- Generic name (nonproprietary)
- nivolumab and hyaluronidase-nvhy
- Active ingredients
- Nivolumab — 120 mg/mLHyaluronidase (Human recombinant) — 2000 U/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761381
- Marketing start
- Listing expires
- Other FDA classes
- Glycoside Hydrolases (Chemical structure)Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0003-6120_1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1aSPL ID 1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1aSPL set ID 7f8c38fa-42f4-4387-9e8c-7a1c66855d8bRxCUI 2700798, 2700805, 2728491, 2728492UNII 31YO63LBSN, 743QUY4VD8
- Pharmacologic class
- Endoglycosidase; Programmed Death Receptor-1 Blocking Antibody
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400003612001followed by a unit qualifier and the quantityPackage 00003-6120-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.1) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. • adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib. (1.1) • adult patients with advanced RCC who have received prior anti-angiogenic therapy. ( 1.1 ) Melanoma …
Excerpt only. Read the full label for complete information.
About NDC 0003-6120
- What is NDC 0003-6120?
- 0003-6120 is the product NDC for Opdivo Qvantig, Nivolumab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL injection, solution, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Opdivo Qvantig (Nivolumab and hyaluronidase-nvhy).
- What is the active ingredient?
- Nivolumab, Hyaluronidase (Human recombinant).
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Opdivo Qvantig?
- 1 other product NDC are listed under this name. See all Opdivo Qvantig NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Opdivo Qvantig products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Opdivo Qvantignivolumab and hyaluronidase-nvhy | Nivolumab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-3120 | 00003-3120-01 |
Other NDCs under BLA 761381
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Opdivo Qvantignivolumab and hyaluronidase-nvhy | Nivolumab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL | Injection, SolutionSubcutaneous | E.R. Squibb & Sons, L.L.C. | 0003-3120 |