acteristics
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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125019 02/19/2002
Zeva lIN
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Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68152-103
Packaging
# NDC Package Description Multilevel Packaging
1 68152-103-03 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 |
