linagliptin and metformin hydrochloride
linagliptin and metformin hydrochloride is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including Jentadueto, Jentadueto XR. Available dosage forms: tablet, tablet, film coated, tablet, film coated, extended release.
Drug Details
- Generic Name
- linagliptin and metformin hydrochloride
- Brand Names
- Jentadueto, Jentadueto XR
- Application Number
- NDA201281
- Sponsor
- Boehringer Ingelheim Pharma GmbH and Co. KG
- NDC Codes
- 9
- Dosage Forms
- TABLET, TABLET, FILM COATED, TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- METFORMIN HYDROCHLORIDE, LINAGLIPTIN
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) ].