Opdivo (nivolumab) NDC 0003-3756

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-3756Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-3756Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0003-3756-14	00003375614	1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3756-14) / 12 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 30, 2021

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.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125554
Marketing start: Aug 30, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 0003-3756_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.

How CPT relates to drug billing

NDC on a medical claim

N400003375614 followed by a unit qualifier and the quantity

Package 00003-3756-14. 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 Aug 12, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125554

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125554
Product	Strength	Form · route	Labeler	Product NDC
Opdivonivolumab	Nivolumab 10 mg/mL	InjectionIntravenous	E.R. Squibb & Sons, L.L.C.	0003-3772
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.	0003-3774