on Guide
No Preservative
Rx only
Genentech
Principal Display Panel - 20 mL Vial Box
PRINCIPAL DISPLAY PANEL - 0.9 ML SYRINGE BOX
NDC 50242-138-01
Actemra®
(tocilizumab)
Injection
162mg/0.9mL
For Subcutaneous
Injection Only
Single Dose Prefilled
Syringe - Discard Unused
Portion
Sterile
ATTENTION
PHARMACIST:
Each patient is required
to receive the enclosed
Medication Guide.
Refrigerate Immediately
Rx only
Each Prefilled Syringe
Contains:
162 mg/0.9 mL
Genentech
10146668
PRINCIPAL DISPLAY PANEL - 0.9 mL Syringe Box
INGREDIENTS AND APPEARANCE
ACTEMRA
tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-135
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (UNII: I031V2H011) (tocilizumab - UNII:I031V2H011) tocilizumab 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)
polysorbate 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50242-135-01 1 in 1 BOX 01/08/2010
1 4 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
BLA BLA125276 01/08/2010
ACTEMRA
tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-136
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (UNII: I031V2H011) (tocilizumab - UNII:I031V2H011) tocilizumab 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)
polysorbate 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50242-136-01 1 in 1 BOX 01/08/2010
1 10 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
BLA BLA125276 01/08/2010
ACTEMRA
tocilizumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-137
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (UNII: I031V2H011) (tocilizumab - UNII:I031V2H |
