NDC Code(s) : 55513-160-01
Packager : Amgen Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BLINCYTOblinatumomab KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-160
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)1.19 mg in 1 mL
LYSINE HYDROCHLORIDE(UNII: JNJ23Q2COM)8.27 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.23 mg in 1 mL
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)34 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)5.25 mg in 1 mL
LYSINE HYDROCHLORIDE(UNII: JNJ23Q2COM)228.38 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)1 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55513-160-011 in 1 PACKAGE 18/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014

LABELER - Amgen Inc(039976196)

Establishment
Name Address ID/FEI Business Operations
Eurofins PROXY Laboratories B.V. 490477955 ANALYSIS(55513-160)

PRINCIPAL DISPLAY PANEL

AMGEN®

35
mcg/vial

1 BLINCYTO® Single-Dose Vial
1 IV Solution Stabilizer Vial

NDC 55513-160-01

BLINCYTO®
(blinatumomab)
for Injection

35 mcg/vial

For Intravenous Infusion Only
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Store in carton to protect from light.
DO NOT SHAKE reconstituted solution.
Dispense the enclosed Medication Guide to each patient.

No Preservative
Single-Dose Vial –
Discard unused portion.

Rx Only

Principal Display Panel - Kit Package