Prescription drug · BLA
Opdualag (Nivolumab and relatlimab-rmbw) NDC 0003-7125
Nivolumab 12 mg/mL; Relatlimab 4 mg/mL · Injection · Intravenous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-7125-11 | 0000371251100003712511 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-7125-11) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 18, 2022 |
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)
- Opdualag
- Generic name (nonproprietary)
- nivolumab and relatlimab-rmbw
- Active ingredients
- Nivolumab — 12 mg/mLRelatlimab — 4 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761234
- Marketing start
- Listing expires
- Other FDA classes
- Lymphocyte Activation Gene-3 Antagonists (Mechanism)Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0003-7125_7c285448-d5b9-4eca-b117-0d791b1b4de3SPL ID 7c285448-d5b9-4eca-b117-0d791b1b4de3SPL set ID b22c9d83-3256-4e17-85f7-f331a504adc6RxCUI 2596778, 2596784UNII 31YO63LBSN, AF75XOF6W3
- Pharmacologic class
- Lymphocyte Activation Gene-3 Blocker; 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
N400003712511followed by a unit qualifier and the quantityPackage 00003-7125-11. 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)
OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
Excerpt only. Read the full label for complete information.
About NDC 0003-7125
- What is NDC 0003-7125?
- 0003-7125 is the product NDC for Opdualag, Nivolumab 12 mg/mL; Relatlimab 4 mg/mL injection, 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?
- Opdualag (Nivolumab and relatlimab-rmbw).
- What is the active ingredient?
- Nivolumab, Relatlimab.
- 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 Opdualag?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.