Use In Special Populations (8.3)].
18. Principal Display Panel
© 2009 Spectrum Pharmaceuticals, Inc.
Irvine, CA 92618
U.S. License No. 1832
Protected by U.S. Patent Nos. 5,736,137, 5,776,456, 5,843,439, 6,207,858, 6,399,061, 6,682,734, 6,994,840, 7,229,620, 7,381,560, 7,422,739 and other patents and patents pending.
Zeva lIN
ibritumomab tiuxetan kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68152-104
Packaging
# NDC Package Description Multilevel Packaging
1 68152-104-04 1 KIT In 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 VIAL 10 mL
Part 3 1 VIAL 2 mL
Part 1 of 3
Zeva lIN
ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBRITUMOMAB TIUXETAN (IBRITUMOMAB TIUXETAN) IBRITUMOMAB TIUXETAN 1.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.8 mg in 1 mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 2 mL In 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Part 2 of 3
FORMULATION BUFFER
ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
ALBUMIN (HUMAN) 7.5 mg in 1 mL
SODIUM CHLORIDE 7.6 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 2.1 mg in 1 mL
PENTETIC ACID 0.395 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.194 mg in 1 mL
POTASSIUM CHLORIDE 0.194 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 10 mL In 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Part 3 of 3
SODIUM ACETATE
ibritumomab tiuxetan injection
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE 6.8 mg in 1 mL
WATER
Product Char |
