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 20mg in1mL
 
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 1VIALIn1BOX contains a VIAL, SINGLE-USE
1  20mLIn1VIAL, SINGLE-USE This package is contained within the BOX(50242-137-01)
2 50242-137-04 4VIALIn1BOX contains a VIAL, SINGLE-USE
2  20mLIn1VIAL, 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 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