oral semaglutide

FDA Drug Profile — OZEMPIC, RYBELSUS

oral semaglutide is listed in the FDA National Drug Code directory with 6 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
6
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 )