IMFINZI
These highlights do not include all the information needed to use IMFINZI safely and effectively. See full prescribing information for IMFINZI. IMFINZI (durvalumab) injection, for intravenous useInitial U.S. Approval: 2017
Approved
Approval ID
8baba4ea-2855-42fa-9bd9-5a7548d4cec3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2023
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Durvalumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-4500
Application NumberBLA761069
Product Classification
M
Marketing Category
C73585
G
Generic Name
Durvalumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 16, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 4.8 mg in 2.4 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.5 mg in 2.4 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DURVALUMABActive
Quantity: 120 mg in 2.4 mL
Code: 28X28X9OKV
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 250 mg in 2.4 mL
Code: 7YIN7J07X4
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6.5 mg in 2.4 mL
Code: X573657P6P
Classification: IACT
Durvalumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-4611
Application NumberBLA761069
Product Classification
M
Marketing Category
C73585
G
Generic Name
Durvalumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 16, 2023
FDA Product Classification
INGREDIENTS (6)
DURVALUMABActive
Quantity: 500 mg in 10 mL
Code: 28X28X9OKV
Classification: ACTIB
HISTIDINEInactive
Quantity: 20 mg in 10 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 27 mg in 10 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2 mg in 10 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 1040 mg in 10 mL
Code: 7YIN7J07X4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT