sitagliptin and metformin hydrochloride
sitagliptin and metformin hydrochloride is listed in the FDA National Drug Code directory with 19 NDC codes, marketed under brand names including JANUMET XR, ZITUVIMET XR, Sitagliptin and Metformin Hydrochloride. Available dosage form: tablet, film coated, extended release.
Drug Details
- Generic Name
- sitagliptin and metformin hydrochloride
- Brand Names
- JANUMET XR, ZITUVIMET XR, Sitagliptin and Metformin Hydrochloride, Sitagliptin and Metformin hydrochloride
- Application Number
- NDA202270
- Sponsor
- Merck Sharp & Dohme LLC
- NDC Codes
- 19
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN
Indications and Usage
1 INDICATIONS AND USAGE JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2) .] JANUMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUMET should not be used in patients with type 1 diabetes. ( 1 ) JANUMET has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 )