saxagliptin
saxagliptin is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Saxagliptin. Available dosage forms: powder, tablet, film coated.
Drug Details
- Generic Name
- saxagliptin
- Brand Names
- Saxagliptin
- Application Number
- ANDA205980
- Sponsor
- SK BIOTEK IRELAND LIMITED
- NDC Codes
- 3
- Dosage Forms
- POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- SAXAGLIPTIN MONOHYDRATE, SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
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.