PENTETIC ACID 0.04 mg in 1 mL
POLYSORBATE 80 0.1 mg in 1 mL
WATER
Packaging
# Item Code Package Description
1 NDC:0003-2327-11 1 VIAL, SINGLE-USE in 1 CARTON
1 50 mL in 1 VIAL, SINGLE-USE
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 LABEL 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 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE HYDROCHLORIDE 3.15 mg in 1 mL
SODIUM CHLORIDE 5.85 mg in 1 mL
MANNITOL 10 mg in 1 mL
PENTETIC ACID 0.04 mg in 1 mL
POLYSORBATE 80 0.1 mg in 1 mL
WATER
Packaging
# Item Code Package Description
1 NDC:0003-2328-22 1 VIAL, SINGLE-USE in 1 CARTON
1 200 mL in 1 VIAL, SINGLE-USE
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)
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