Trulicity
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY. TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014
Approved
Approval ID
463050bd-2b1c-40f5-b3c3-0a04bb433309
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dulaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-1433
Application NumberBLA125469
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dulaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 19, 2021
FDA Product Classification
INGREDIENTS (6)
Trisodium Citrate DihydrateInactive
Quantity: 1.37 mg in 0.5 mL
Code: B22547B95K
Classification: IACT
DulaglutideActive
Quantity: 0.75 mg in 0.5 mL
Code: WTT295HSY5
Classification: ACTIB
Anhydrous Citric AcidInactive
Quantity: 0.07 mg in 0.5 mL
Code: XF417D3PSL
Classification: IACT
MannitolInactive
Quantity: 23.2 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.10 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Dulaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-3182
Application NumberBLA125469
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dulaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 19, 2021
FDA Product Classification
INGREDIENTS (6)
DulaglutideActive
Quantity: 4.5 mg in 0.5 mL
Code: WTT295HSY5
Classification: ACTIB
Anhydrous Citric AcidInactive
Quantity: 0.07 mg in 0.5 mL
Code: XF417D3PSL
Classification: IACT
MannitolInactive
Quantity: 23.2 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateInactive
Quantity: 1.37 mg in 0.5 mL
Code: B22547B95K
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.125 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
Dulaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-2236
Application NumberBLA125469
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dulaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 19, 2021
FDA Product Classification
INGREDIENTS (6)
DulaglutideActive
Quantity: 3.0 mg in 0.5 mL
Code: WTT295HSY5
Classification: ACTIB
Trisodium Citrate DihydrateInactive
Quantity: 1.37 mg in 0.5 mL
Code: B22547B95K
Classification: IACT
Anhydrous Citric AcidInactive
Quantity: 0.07 mg in 0.5 mL
Code: XF417D3PSL
Classification: IACT
MannitolInactive
Quantity: 23.2 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.125 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Dulaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-1434
Application NumberBLA125469
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dulaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 19, 2021
FDA Product Classification
INGREDIENTS (6)
DulaglutideActive
Quantity: 1.5 mg in 0.5 mL
Code: WTT295HSY5
Classification: ACTIB
Anhydrous Citric AcidInactive
Quantity: 0.07 mg in 0.5 mL
Code: XF417D3PSL
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.10 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
MannitolInactive
Quantity: 23.2 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateInactive
Quantity: 1.37 mg in 0.5 mL
Code: B22547B95K
Classification: IACT