Prescription drug · BLA
Imfinzi (Durvalumab) NDC 0310-4500
Durvalumab 120 mg/2.4mL · Injection, Solution · Intravenous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| 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 LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761069
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N400310450012followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 0310-4500
- What is NDC 0310-4500?
- 0310-4500 is the product NDC for Imfinzi (durvalumab), Durvalumab 120 mg/2.4mL injection, solution, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imfinzi (Durvalumab).
- What is the active ingredient?
- Durvalumab.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imfinzi?
- 1 other product NDC are listed under this name. See all Imfinzi NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9173, Injection, durvalumab, 10 mg. See Billing references above.
Related NDCs: other Imfinzi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imfinzidurvalumab | Durvalumab 500 mg/10mL | Injection, SolutionIntravenous | AstraZeneca Pharmaceuticals LP | 0310-4611 | 00310-4611-50 |
Other NDCs under BLA 761069
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 |
|---|---|---|---|---|
| Imfinzidurvalumab | Durvalumab 500 mg/10mL | Injection, SolutionIntravenous | AstraZeneca Pharmaceuticals LP | 0310-4611 |