NDC Code(s) : 0310-6540-01, 0310-6540-04, 0310-6540-85
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BYDUREON BCiseexenatide INJECTION, SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-6540
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EXENATIDE(UNII: 9P1872D4OL)
(EXENATIDE - UNII:9P1872D4OL) 		EXENATIDE2 mg in 0.85 mL
Inactive Ingredients
Ingredient Name Strength
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW)(UNII: QD923V64H3)
SUCROSE(UNII: C151H8M554)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0310-6540-044 in 1 CARTON 12/01/2017
1NDC:0310-6540-010.85 mL in 1 CARTRIDGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0310-6540-851 in 1 CARTON 12/01/2017
20.85 mL in 1 CARTRIDGE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209210 12/01/2017

LABELER - AstraZeneca Pharmaceuticals LP(054743190)

REGISTRANT - AstraZeneca PLC(230790719)

PRINCIPAL DISPLAY PANEL

NDC 0310-6540-01
2 mg single-dose autoinjector

Medication requires mixing before use

Store FLAT in a refrigerator 36-46°F

(2-8°C)

Once-weekly

BYDUREON BCise®
(exenatide) extended-release

injectable suspension

For subcutaneous use only

Rx only                      AstraZeneca

2mg pen label

PRINCIPAL DISPLAY PANEL

NDC 0310-6540-04
Once-Weekly

BYDUREON BCise®                                2 mg single-dose autoinjector
(exenatide) extended-release

injectable suspension

For subcutaneous use only

Dispense with enclosed Medication Guide

to each patient.

Store FLAT in refrigerator 36-46°F (2-8°C).

Total Quantity: 4 x Single-Dose Autoinjectors
Use one autoinjector every week

Each autoinjector delivers a 2 mg dose

Rx only                         AstraZeneca

2mg pen carton