02/22/2013
KADCYLA
trastuzumab emtansine injection, powder, lyophilized, for solution

Product Information
 
Product Type

HUMAN PRESCRIPTION DRUG LABEL

Item Code (Source)

NDC:50242-087

Route of Administration

INTRAVENOUS

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)