ion Only
Reconstitute and Dilute prior
to administration
Single-Dose Vial –
Discard Unused Portion
KEEP REFRIGERATED
Rx only
1 vial
Genentech
10135258
PRINCIPAL DISPLAY PANEL - 160 mg Vial Label
NDC 50242-087-01
Kadcyla™
(ado-trastuzumab
emtansine)
For Injection
160 mg per vial
For Intravenous Infusion Only
Reconstitute and Dilute prior
to administration
Single-Dose Vial –
Discard Unused Portion
KEEP REFRIGERATED
Rx only
1 vial
Genentech
4862100
KADCYLA
trastuzumab emtansine injection, powder, lyophilized, for solution
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC:50242-088
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:50242-088-01
1 in 1 CARTON
1
5 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
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)
