TRULICITY- dulaglutide injection, solution 
Eli Lilly Italia SPA

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Trulicity

NDC: 54568-433-71

Store between +2°C and +8°C

Do not freeze

PRE-FILLED AUTO-INJECTOR

TRULICITY 0.75MG/0.5ML X4PEND AM

Item Code: PS1433004AM

Expiration Date:

Lot Num.:

Quantity:

Eli Lilly Italia

via Gramsci 731-733

Sesto Fiorentino Italia

Lilly

PACKAGE LABEL – DULAGLUTIDE 0.75 mg / 0.5 mL Semi-finished Syringes

NDC: 54568-434-71

Store between +2°C and +8°C

Do not freeze

PRE-FILLED AUTO-INJECTOR

TRULICITY 1.5MG/0.5ML X4PEND AM

Item Code: PS1434004AM

Expiration Date:

Lot Num.:

Quantity:

Eli Lilly Italia

via Gramsci 731-733

Sesto Fiorentino Italia

Lilly

PACKAGE LABEL – DULAGLUTIDE 1.5 mg / 0.5 mL Semi-finished Syringes
TRULICITY 
dulaglutide injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54568-433
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dulaglutide (UNII: WTT295HSY5) (Dulaglutide - UNII:WTT295HSY5) Dulaglutide0.75 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Trisodium Citrate Dihydrate (UNII: B22547B95K) 1.37 mg  in 0.5 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) 0.07 mg  in 0.5 mL
Mannitol (UNII: 3OWL53L36A) 23.2 mg  in 0.5 mL
Polysorbate 80 (UNII: 6OZP39ZG8H) 0.10 mg  in 0.5 mL
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54568-433-7120 in 1 CASE10/03/2016
14 in 1 CARTON
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:54568-433-6324 in 1 CASE10/03/2016
22 in 1 CARTON
20.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractBLA12546911/07/2014
TRULICITY 
dulaglutide injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54568-434
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dulaglutide (UNII: WTT295HSY5) (Dulaglutide - UNII:WTT295HSY5) Dulaglutide1.5 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
Trisodium Citrate Dihydrate (UNII: B22547B95K) 1.37 mg  in 0.5 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) 0.07 mg  in 0.5 mL
Mannitol (UNII: 3OWL53L36A) 23.2 mg  in 0.5 mL
Polysorbate 80 (UNII: 6OZP39ZG8H) 0.10 mg  in 0.5 mL
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54568-434-7120 in 1 CASE10/03/2016
14 in 1 CARTON
10.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:54568-434-6324 in 1 CASE10/03/2016
22 in 1 CARTON
20.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractBLA12546911/07/2014
Labeler - Eli Lilly Italia SPA (428316723)

Revised: 10/2017
Document Id: 56b5469a-7f3a-4980-8750-a05826985d59
Set id: 56b5469a-7f3a-4980-8750-a05826985d59
Version: 1
Effective Time: 20171010
 
Eli Lilly Italia SPA