linagliptin and metformin hydrochloride
linagliptin and metformin hydrochloride is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Jentadueto XR, Jentadueto. Available dosage forms: tablet, film coated, extended release, tablet, tablet, film coated.
Drug Details
- Generic Name
- linagliptin and metformin hydrochloride
- Brand Names
- Jentadueto XR, Jentadueto
- Application Number
- NDA208026
- Sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC Codes
- 14
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, TABLET, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- LINAGLIPTIN, METFORMIN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . JENTADUETO XR is a combination of linagliptin, 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 Not recommended in patients with type 1 diabetes mellitus ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2) ].