Imjudo (tremelimumab) NDC 0310-4535

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-4535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-4535Add 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
0310-4535-30	00310453530	1 VIAL in 1 CARTON (0310-4535-30) / 15 mL in 1 VIALMarketed from Oct 21, 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): Imjudo
Generic name (nonproprietary): tremelimumab
Active ingredients: Tremelimumab — 300 mg/15mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: AstraZeneca Pharmaceuticals LP
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761289
Marketing start: Oct 21, 2022
Listing expires: Dec 31, 2027
Other FDA classes: CTLA-4-directed Antibody Interactions (Mechanism)Increased T Lymphocyte Activation (Physiologic effect)
Identifiers: Product ID 0310-4535_292bb46c-e55a-4acf-9dd1-fbe684ad1363SPL ID 292bb46c-e55a-4acf-9dd1-fbe684ad1363SPL set ID 6690679c-be2f-4588-a2e4-89fff74dd6beRxCUI 2619317, 2619323, 2619325, 2619326UNII QEN1X95CIX
Pharmacologic class: CTLA-4-directed 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.

How CPT relates to drug billing

NDC on a medical claim

N400310453530 followed by a unit qualifier and the quantity

Package 00310-4535-30. 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)

IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ( 1.2 ) 1.1 Hepatocellular Carcinoma IMJUDO, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1.2 Non-Small Ce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761289

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

FDA NDC Directory listings under BLA 761289
Product	Strength	Form · route	Labeler	Product NDC
Imjudotremelimumab	Tremelimumab 25 mg/1.25mL	Injection, SolutionIntravenous	AstraZeneca Pharmaceuticals LP	0310-4505