tirzepatide

FDA Drug Profile — ZEPBOUND, Mounjaro, Zepbound KwikPen, Zepbound, Mounjaro KwikPen

Drug Details

Generic Name
tirzepatide
Brand Names
ZEPBOUND, Mounjaro, Zepbound KwikPen, Zepbound, Mounjaro KwikPen
Application Number
NDA217806
Sponsor
BSP Pharmaceuticals SpA
NDC Codes
50
Dosage Forms
INJECTION, SOLUTION, POWDER
Routes
SUBCUTANEOUS
Active Ingredients
TIRZEPATIDE

Indications and Usage

1 INDICATIONS AND USAGE MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )