DEA Schedule

Active Ingredient/Active Moiety
 
Ingredient Name

Basis of Strength

Strength
 
TRASTUZUMAB EMTANSINE (TRASTUZUMAB EMTANSINE)

TRASTUZUMAB EMTANSINE

20 mg  in 1 mL
 
Inactive Ingredients
 
Ingredient Name

Strength
 
SUCROSE

60 mg  in 1 mL
 
SUCCINIC ACID

1.18 mg  in 1 mL
 
SODIUM HYDROXIDE

0.45 mg  in 1 mL
 
POLYSORBATE 20

0.2 mg  in 1 mL
 

WATER

 
Packaging
 
#

Item Code

Package Description
 
1

NDC:50242-087-01

1 in 1 CARTON
 
1
8 mL in 1 VIAL, SINGLE-USE

Marketing Information
 
Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

BLA

BLA125427

02/22/2013
Labeler - Genentech, Inc. (080129000)
Establishment
 
Name

Address

ID/FEI

Business Operations

Genentech, Inc. (Hillsboro)
833220176

LABEL(50242-088, 50242-087), PACK(50242-088, 50242-087)