Prescription drug · BLA
Imjudo (Tremelimumab) NDC 0310-4535
Tremelimumab 300 mg/15mL · Injection, Solution · Intravenous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| 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 LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761289
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N400310453530followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 0310-4535
- What is NDC 0310-4535?
- 0310-4535 is the product NDC for Imjudo (tremelimumab), Tremelimumab 300 mg/15mL 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?
- Imjudo (Tremelimumab).
- What is the active ingredient?
- Tremelimumab.
- 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 Imjudo?
- 1 other product NDC are listed under this name. See all Imjudo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imjudo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imjudotremelimumab | Tremelimumab 25 mg/1.25mL | Injection, SolutionIntravenous | AstraZeneca Pharmaceuticals LP | 0310-4505 | 00310-4505-25 |
Other NDCs under BLA 761289
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 |
|---|---|---|---|---|
| Imjudotremelimumab | Tremelimumab 25 mg/1.25mL | Injection, SolutionIntravenous | AstraZeneca Pharmaceuticals LP | 0310-4505 |