dapagliflozin
dapagliflozin is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including dapagliflozin. Available dosage forms: tablet, tablet, film coated, powder.
Drug Details
- Generic Name
- dapagliflozin
- Brand Names
- dapagliflozin
- Application Number
- ANDA211506
- Sponsor
- Macleods Pharmaceuticals Limited
- NDC Codes
- 7
- Dosage Forms
- TABLET, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- DAPAGLIFLOZIN, DAPAGLIFLOZIN PROPANEDIOL
Indications and Usage
1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. • Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. ( 1 ) • 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 use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) • Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action. ( 1 )