NDC Code(s) : 66914-2327-9, 66914-2328-9
Packager : Baxter Pharmaceutical Solutions, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

YERVOYipilimumab INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66914-2327
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPILIMUMAB(UNII: 6T8C155666)
(IPILIMUMAB - UNII:6T8C155666) 		IPILIMUMAB5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE HYDROCHLORIDE(UNII: 383V75M34E)3.15 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)5.85 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)10 mg in 1 mL
PENTETIC ACID(UNII: 7A314HQM0I)0.04 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66914-2327-912 in 1 CARTON
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 03/25/2011
YERVOYipilimumab INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66914-2328
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPILIMUMAB(UNII: 6T8C155666)
(IPILIMUMAB - UNII:6T8C155666) 		IPILIMUMAB5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE HYDROCHLORIDE(UNII: 383V75M34E)3.15 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)5.85 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)10 mg in 1 mL
PENTETIC ACID(UNII: 7A314HQM0I)0.04 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66914-2328-910 in 1 CARTON
140 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 03/25/2011

PRINCIPAL DISPLAY PANEL

FOR EXPORT
YERVOY (IPILIMUMAB) SOLUTION INJECT 50MG/10ML 1X10ML VIAL VE
1 CASE X 12 VIALS X 10 MILLILITER

REFRIGERATE AT 2°C TO 8°C (36°F TO 46°F).
DO NOT FREEZE OR SHAKE. PROTECT FROM LIGHT.


MANUFACTURED BY: BRISTOL-MYERS SQUIBB COMPANY
PRINCETON, NEW JERSEY 08543 USA

yervoy-50mg10ml-shipperlbl.jpg

PRINCIPAL DISPLAY PANEL

FOR EXPORT
YERVOY (IPILIMUMAB) SOLUTION INJECT 200MG/40ML 1X40ML VIAL VE
1 CASE X 10 VIALS X 40 MILLILITER

REFRIGERATE AT 2°C TO 8°C (36°F TO 46°F).
DO NOT FREEZE OR SHAKE. PROTECT FROM LIGHT.


MANUFACTURED BY: BRISTOL-MYERS SQUIBB COMPANY
PRINCETON, NEW JERSEY 08543 USA

yervoy-200mg40ml-shipperlbl.jpg