oral semaglutide
oral semaglutide is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand names including OZEMPIC, RYBELSUS. Available dosage form: tablet.
Drug Details
- Generic Name
- oral semaglutide
- Brand Names
- OZEMPIC, RYBELSUS
- Application Number
- NDA213051
- Sponsor
- Novo Nordisk Pharmaceutical Industries, LP
- NDC Codes
- 12
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- SEMAGLUTIDE
Indications and Usage
1 INDICATIONS AND USAGE RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 )