Imfinzi (durvalumab) NDC 0310-4500

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-4500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-4500Add 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
0310-4500-12	00310450012	1 VIAL in 1 CARTON (0310-4500-12) / 2.4 mL in 1 VIALMarketed from May 1, 2017

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): Imfinzi
Generic name (nonproprietary): durvalumab
Active ingredients: Durvalumab — 120 mg/2.4mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: AstraZeneca Pharmaceuticals LP
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761069
Marketing start: May 1, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Monoclonal (Chemical structure)Programmed Death Ligand-1 Antagonists (Mechanism)Programmed Death Ligand-1-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 0310-4500_5826517b-d2d2-4636-ad9c-0dc676abad9eSPL ID 5826517b-d2d2-4636-ad9c-0dc676abad9eSPL set ID 8baba4ea-2855-42fa-9bd9-5a7548d4cec3RxCUI 1919507, 1919512, 1919515, 1919516UNII 28X28X9OKV
Pharmacologic class: Programmed Death Ligand-1 Blocker

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

J9173 — Injection, durvalumab, 10 mg

Billing unit: 10 mg. Units on the claim = dose given ÷ 10 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

N400310450012 followed by a unit qualifier and the quantity

Package 00310-4500-12. 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 31, 2026.

Indications (excerpt from the label)

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. ( 1.1 ) • as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.1 ) • in c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761069

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

FDA NDC Directory listings under BLA 761069
Product	Strength	Form · route	Labeler	Product NDC
Imfinzidurvalumab	Durvalumab 500 mg/10mL	Injection, SolutionIntravenous	AstraZeneca Pharmaceuticals LP	0310-4611