Prescription drug · BLA
Opdivo (Nivolumab) NDC 0003-3772
Nivolumab 10 mg/mL · Injection · Intravenous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-3772-11 | 0000337721100003377211 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 22, 2014 |
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
- Generic name (nonproprietary)
- nivolumab
- Active ingredients
- Nivolumab — 10 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 125554
- Marketing start
- Listing expires
- Other FDA classes
- Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0003-3772_1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ceSPL ID 1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ceSPL set ID f570b9c4-6846-4de2-abfa-4d0a4ae4e394RxCUI 1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081UNII 31YO63LBSN
- Pharmacologic class
- 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 codeMed-Code curated
J9299 — Injection, nivolumab, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
- 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
N400003377211followed by a unit qualifier and the quantityPackage 00003-3772-11. 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)
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1) • for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3) • adult patients with resectable (tumors ≥4 cm or node positive…
Excerpt only. Read the full label for complete information.
About NDC 0003-3772
- What is NDC 0003-3772?
- 0003-3772 is the product NDC for Opdivo (nivolumab), Nivolumab 10 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?
- Opdivo (Nivolumab).
- What is the active ingredient?
- Nivolumab.
- 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?
- 3 other product NDCs are listed under this name. See all Opdivo NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9299, Injection, nivolumab, 1 mg. See Billing references above.
Related NDCs: other Opdivo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3756 | 00003-3756-14 |
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3734 | 00003-3734-13 |
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3774 | 00003-3774-12 |
Other NDCs under BLA 125554
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 |
|---|---|---|---|---|
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3734 |
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3756 |
| Opdivonivolumab | Nivolumab 10 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-3774 |