011) 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:50242-137-01 1 in 1 BOX 01/08/2010
1 20 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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-138
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (UNII: I031V2H011) (tocilizumab - UNII:I031V2H011) tocilizumab 180 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
polysorbate 80 (UNII: 6OZP39ZG8H)
histidine (UNII: 4QD397987E)
histidine monohydrochloride monohydrate (UNII: X573657P6P)
arginine (UNII: 94ZLA3W45F)
arginine hydrochloride (UNII: F7LTH1E20Y)
methionine (UNII: AE28F7PNPL)
water (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50242-138-01 1 in 1 BOX 10/21/2013
1 0.9 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125472 10/21/2013
LABELER - GENENTECH, INC. (080129000)
REGISTRANT - GENENTECH, INC. (080129000)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Roche Pharma AG 315009878 ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138)
ESTABLISHMENT
Name Address ID/FEI Business Operations
F. Hoffmann-La Roche Ltd 485244961 LABEL(50242-138) , ANALYSIS(50242-138)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Genentech, Inc. (Oceanside) 146373191 ANALYSIS(50242-135, 50242-136, 50242-137, 50242-138) , API MANUFACTURE(50242-135, 50242-136, 50242-137, 50242-138)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Genentech, Inc. (SSF) 080129000 ANALYSIS(50242-135, 50242-136, 50242-137) , MANUFACTURE(50242-135, 50242-136, 50242-137)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Roche Diagnostics GmbH 315028860 ANALYSIS(50242-135, 50242-136, 50242-137)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Genentech, Inc. (Vacaville) 004074162 ANALYSIS(502 |
