imfinzi

Generic: durvalumab

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

Drug Facts

Product Profile

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

durvalumab 500 mg/10mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-4611
Product ID 0310-4611_686baf25-364f-4124-858f-151f1dae3756
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761069
Listing Expiration 2026-12-31
Marketing Start 2017-05-01

Pharmacologic Class

Established (EPC)
programmed death ligand-1 blocker [epc]
Mechanism of Action
programmed death ligand-1 antagonists [moa] programmed death ligand-1-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03104611
Hyphenated Format 0310-4611

Supplemental Identifiers

RxCUI
1919507 1919512 1919515 1919516
UNII
28X28X9OKV
NUI
N0000193338 N0000193337 N0000193336 M0001357

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 imfinzi (source: ndc)
Generic Name durvalumab (source: ndc)
Application Number BLA761069 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0310-4611-50 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL

Ingredients (1)

durvalumab (500 mg/10mL)

Linked Drug Pages (1)

IMFINZI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "686baf25-364f-4124-858f-151f1dae3756", "openfda": {"nui": ["N0000193338", "N0000193337", "N0000193336", "M0001357"], "unii": ["28X28X9OKV"], "rxcui": ["1919507", "1919512", "1919515", "1919516"], "spl_set_id": ["8baba4ea-2855-42fa-9bd9-5a7548d4cec3"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Programmed Death Ligand-1 Blocker [EPC]"], "pharm_class_moa": ["Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0310-4611-50)  / 10 mL in 1 VIAL", "package_ndc": "0310-4611-50", "marketing_start_date": "20170501"}], "brand_name": "IMFINZI", "product_id": "0310-4611_686baf25-364f-4124-858f-151f1dae3756", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1 Blocker [EPC]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "product_ndc": "0310-4611", "generic_name": "Durvalumab", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMFINZI", "active_ingredients": [{"name": "DURVALUMAB", "strength": "500 mg/10mL"}], "application_number": "BLA761069", "marketing_category": "BLA", "marketing_start_date": "20170501", "listing_expiration_date": "20261231"}