sp;
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 50242-136-01 1 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1 10 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-136-01)
2 50242-136-04 4 VIAL In 1 BOX contains a VIAL, SINGLE-USE
2 10 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-136-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
ACTEMRA
tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-137
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (tocilizumab) tocilizumab 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sucrose
polysorbate 80
sodium phosphate, dibasic, dodecahydrate
sodium phosphate, monobasic, dihydrate
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 50242-137-01 1 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1 20 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-137-01)
2 50242-137-04 4 VIAL In 1 BOX contains a VIAL, SINGLE-USE
2 20 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-137-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010
Labeler - Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Chugai Pharma Manufacturing Co Ltd 716464891 ANALYSIS, API MANUFACTURE, MANUFACTURE
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 482242971 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 MANUFACTURE
Revised: 01/2010Genentech, Inc.
