imjudo

Generic: tremelimumab

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name imjudo
Generic Name tremelimumab
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tremelimumab 25 mg/1.25mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-4505
Product ID 0310-4505_390ff583-8e40-4690-ac4c-b4eaef2229d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761289
Listing Expiration 2026-12-31
Marketing Start 2022-10-21

Pharmacologic Class

Established (EPC)
ctla-4-directed blocking antibody [epc]
Mechanism of Action
ctla-4-directed antibody interactions [moa]
Physiologic Effect
increased t lymphocyte activation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03104505
Hyphenated Format 0310-4505

Supplemental Identifiers

RxCUI
2619317 2619323 2619325 2619326
UNII
QEN1X95CIX
NUI
N0000182635 N0000182634 N0000182157

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imjudo (source: ndc)
Generic Name tremelimumab (source: ndc)
Application Number BLA761289 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/1.25mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0310-4505-25) / 1.25 mL in 1 VIAL
source: ndc

Packages (1)

0310-4505-25 1 VIAL in 1 CARTON (0310-4505-25) / 1.25 mL in 1 VIAL

Ingredients (1)

tremelimumab (25 mg/1.25mL)

Linked Drug Pages (1)

IMJUDO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "390ff583-8e40-4690-ac4c-b4eaef2229d2", "openfda": {"nui": ["N0000182635", "N0000182634", "N0000182157"], "unii": ["QEN1X95CIX"], "rxcui": ["2619317", "2619323", "2619325", "2619326"], "spl_set_id": ["6690679c-be2f-4588-a2e4-89fff74dd6be"], "pharm_class_pe": ["Increased T Lymphocyte Activation [PE]"], "pharm_class_epc": ["CTLA-4-directed Blocking Antibody [EPC]"], "pharm_class_moa": ["CTLA-4-directed Antibody Interactions [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0310-4505-25)  / 1.25 mL in 1 VIAL", "package_ndc": "0310-4505-25", "marketing_start_date": "20221021"}], "brand_name": "IMJUDO", "product_id": "0310-4505_390ff583-8e40-4690-ac4c-b4eaef2229d2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CTLA-4-directed Antibody Interactions [MoA]", "CTLA-4-directed Blocking Antibody [EPC]", "Increased T Lymphocyte Activation [PE]"], "product_ndc": "0310-4505", "generic_name": "tremelimumab", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMJUDO", "active_ingredients": [{"name": "TREMELIMUMAB", "strength": "25 mg/1.25mL"}], "application_number": "BLA761289", "marketing_category": "BLA", "marketing_start_date": "20221021", "listing_expiration_date": "20261231"}