FDA label
What is Rybelsus used for?
Rybelsus contains semaglutide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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.”
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Rybelsus, tablet
Indications and Usage, quoted from the label by Novo Nordisk Pharmaceutical Industries, LP (NDA213051). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 27f15fac-7d98-4114-a2ec-92494a91da98, version 14, effective January 30, 2026. NDC 0169-4303, one of 3 listings for this product.
Questions
What is Rybelsus used for?
The FDA label says: “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.”
What drug class is Rybelsus?
FDA lists semaglutide in the GLP-1 Receptor Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Rybelsus
- Is Rybelsus a controlled substance?Federal schedule
- Generic for RybelsusFDA Orange Book
- Generic for OzempicFDA Orange Book
- Generic for WegovyFDA Orange Book
- Generic for Wegovy FlextouchFDA Orange Book
- Generic for Wegovy HdFDA Orange Book
- GLP-1 Receptor Agonists listFDA drug class
- Rybelsus Medicare Part D coverageBy plan and state
- NDC 0169-4303Rybelsus NDC record
- NDC 0169-4307Rybelsus NDC record
- NDC 0169-4314Rybelsus NDC record