TRULICITY

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

A-S Medication Solutions

DUNS Number

830016429

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

50090-6571

Application Number

BLA125469

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS

Effective Date

January 19, 2021

Ingredients

Anhydrous Citric AcidInactive

Code: XF417D3PSLClass: IACTQuantity: 0.07 mg in 0.5 mL

MannitolInactive

Code: 3OWL53L36AClass: IACTQuantity: 23.2 mg in 0.5 mL

Code: WTT295HSY5Class: ACTIBQuantity: 3.0 mg in 0.5 mL

Trisodium Citrate DihydrateInactive

Code: B22547B95KClass: IACTQuantity: 1.37 mg in 0.5 mL

Polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 0.125 mg in 0.5 mL

WaterInactive

Code: 059QF0KO0RClass: IACT