NDC Code(s) : 0310-4505-25, 0310-4535-30
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IMJUDOtremelimumab INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-4505
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TREMELIMUMAB(UNII: QEN1X95CIX)
(TREMELIMUMAB - UNII:QEN1X95CIX) 		TREMELIMUMAB25 mg in 1.25 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)0.1 mg in 1.25 mL
HISTIDINE(UNII: 4QD397987E)1 mg in 1.25 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)4 mg in 1.25 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.3 mg in 1.25 mL
TREHALOSE(UNII: B8WCK70T7I)105 mg in 1.25 mL
WATER(UNII: 059QF0KO0R)1.2 g in 1.25 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-4505-251 in 1 CARTON 21/10/2022
11.25 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 BLA761289 10/21/2022
IMJUDOtremelimumab INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-4535
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TREMELIMUMAB(UNII: QEN1X95CIX)
(TREMELIMUMAB - UNII:QEN1X95CIX) 		TREMELIMUMAB300 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)1.5 mg in 15 mL
HISTIDINE(UNII: 4QD397987E)10 mg in 15 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)49 mg in 15 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)3 mg in 15 mL
TREHALOSE(UNII: B8WCK70T7I)1260 mg in 15 mL
WATER(UNII: 059QF0KO0R)14 g in 15 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-4535-301 in 1 CARTON 21/10/2022
115 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 BLA761289 10/21/2022

LABELER - AstraZeneca Pharmaceuticals LP(054743190)

REGISTRANT - AstraZeneca PLC(230790719)

PRINCIPAL DISPLAY PANEL

NDC 0310-4535-30 Rx only

IMJUDO®300 mg/15 mL

(tremelimumab-actl) (20 mg/mL

Injection

For Intravenous Infusion After Dilution

Single-dose vial. Discard unused portion.

Attention Pharmacist:

Dispense the accompanying Medication Guide

to each patient.

AstraZeneca

300_mg

PRINCIPAL DISPLAY PANEL

NDC 0310-4505-25 Rx only

IMJUDO®25 mg/1.25mL

(tremelimumab-actl) (20 mg/mL

Injection

For Intravenous Infusion After Dilution

Single-dose vial. Discard unused portion.

Attention Pharmacist:

Dispense the accompanying Medication Guide

to each patient.

AstraZeneca

25_mg