50 mg/mL)
For Intravenous Infusion After Dilution
Single-dose vial. Discard unused portion.
Store at 2° to 8°C (36° to 46°F).
Do not freeze or shake.
Keep vial in original carton to protect from light.
Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.
Do not use if vial seal is broken or missing.
Must dilute before use.
See prescribing information.
AstraZeneca
120mg/2.5mL Vial
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PACKAGE/LABEL DISPLAY PANEL
NDC 0310-4611-50
Rx only
IMFINZI™
(durvalumab)
Injection
500 mg/10 mL
(50 mg/mL)
For Intravenous Infusion After Dilution
Single-dose vial. Discard unused portion.
Store at 2° to 8°C (36° to 46°F).
Do not freeze or shake.
Keep vial in original carton to protect from light.
Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.
Do not use if vial seal is broken or missing.
Must dilute before use.
See prescribing information.
AstraZeneca
500mg/10mL Vial
INGREDIENTS AND APPEARANCE
IMFINZI
durvalumab injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-4500
Route of Administration INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
DURVALUMAB (UNII: 28X28X9OKV) (DURVALUMAB - UNII:28X28X9OKV) DURVALUMAB 120 mg in 2.4 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
HISTIDINE (UNII: 4QD397987E) 4.8 mg in 2.4 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (UNII: X573657P6P) 6.5 mg in 2.4 mL
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4) 250 mg in 2.4 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.5 mg in 2.4 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0310-4500-12 1 in 1 CARTON 05/01/2017
1 2.4 mL in 1 VIAL; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761069 05/01/2017
IMFINZI
durvalumab injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-4611
Route of Administration INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
DURVALUMAB (UNII: 28X28X9OKV) (DURVALUMAB - UNII:28X28X9OKV) DURVALUMAB 500 mg in 10 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
HISTIDINE (UNII: 4QD397987E) 20 mg in 10 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (UNII: X573657P6P) 27 mg in 10 mL
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4) 1040 mg in 10 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 2 mg in 10 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0310-4611-50 1 in 1 CARTON 05/01/2017
1 10 mL in 1 VIAL; Type 0: Not a Combination Product
MARKETING INFOR |
