saxagliptin and metformin
saxagliptin and metformin is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Saxagliptin and Metformin. Available dosage form: tablet, film coated, extended release.
Drug Details
- Generic Name
- saxagliptin and metformin
- Brand Names
- Saxagliptin and Metformin
- Application Number
- ANDA205981
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE, METFORMIN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14 )]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) 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 for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 ) 1.1 Limitations of Use Saxagliptin and metformin hydrochloride extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.