1281558A2
Issued: March 2011
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REPRESENTATIVE PACKAGING
NDC 0003-2327-11
Rx only
YERVOYTM
(ipilimumab)
Injection
50 mg/10 mL
(5 mg/mL)
For Intravenous Infusion Only
Single-use vial; Discard unused portion
DISPENSE ENCLOSED MEDICATION
GUIDE TO EACH PATIENT
Bristol-Myers Squibb
---------------------------------------------
REPRESENTATIVE PACKAGING
NDC 0003-2328-22
Rx only
YERVOYTM
(ipilimumab)
Injection
200 mg/40 mL
(5 mg/mL)
For Intravenous Infusion Only
Single-use vial; Discard unused portion
DISPENSE ENCLOSED MEDICATION
GUIDE TO EACH PATIENT
Bristol-Myers Squibb
YERVOY
ipilimumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-2327
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPILIMUMAB (IPILIMUMAB) IPILIMUMAB 5mg in1mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE HYDROCHLORIDE 3.15mg in1mL
SODIUM CHLORIDE 5.85mg in1mL
MANNITOL 10mg in1mL
PENTETIC ACID 0.04mg in1mL
POLYSORBATE 80 0.1mg in1mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0003-2327-11 1 VIAL, SINGLE-USE ( VIAL) in 1 CARTON contains a VIAL, SINGLE-USE
1 50 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON(0003-2327-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125377 03/25/2011
YERVOY
ipilimumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0003-2328
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPILIMUMAB (IPILIMUMAB) IPILIMUMAB 5mg in1mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE HYDROCHLORIDE 3.15mg in1mL
SODIUM CHLORIDE 5.85mg in1mL
MANNITOL 10mg in1mL
PENTETIC ACID 0.04mg in1mL
POLYSORBATE 80 0.1mg in1mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0003-2328-22 1 VIAL, SINGLE-USE ( VIAL) in 1 CARTON contains a VIAL, SINGLE-USE
1 200 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON(0003-2328-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125377 03/25/2011
Labeler -E.R. Squibb & Sons, L.L.C. (011550092)
