Patient Home
Welcome to Health Vidya. Discover trusted care and your own health — all in one place.
These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014
Medication labelWhy this: Advisory · dailymed-prescription
Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use • Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2)]. • Because of the metformin HCl component, the use of dapagliflozin and metformin hydrochloride extended-release tablets is limited to patients with type 2 diabetes mellitus for all indications. • Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and metformin hydrochloride extended-release tablets are not expected to be effective in these populations. Pediatric use information is approved for AstraZeneca AB’s Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.
- generic_name
- dapagliflozin and metformin hydrochloride
- product_names
- Dapagliflozin and Metformin Hydrochloride
- ndc
- 33342-406, 33342-407, 33342-408, 33342-409, 33342-406-07, 33342-406-09, 33342-406-10, 33342-406-15, 33342-406-66, 33342-406-06, 33342-407-07, 33342-407-09, 33342-407-10, 33342-407-15, 33342-407-66, 33342-407-06, 33342-408-07, 33342-408-09, 33342-408-10, 33342-408-15, 33342-408-66, 33342-408-06, 33342-409-07, 33342-409-09, 33342-409-10, 33342-409-15, 33342-409-66, 33342-409-06
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en