FDA label
What is Januvia used for?
Januvia contains sitagliptin. 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: “JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
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Januvia, tablet, film coated
Indications and Usage, quoted from the label by Merck Sharp & Dohme LLC (NDA021995). Cross-references to other label sections are left out.
JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
JANUVIA should not be used in patients with type 1 diabetes.
JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA.
Source: DailyMed label, set id f85a48d0-0407-4c50-b0fa-7673a160bf01, version 71, effective November 14, 2024. NDC 0006-0112, one of 11 listings for this product.
Questions
What is Januvia used for?
The FDA label says: “JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
What drug class is Januvia?
FDA lists sitagliptin in the Dipeptidyl Peptidase 4 Inhibitor 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 Januvia
- Is Januvia a controlled substance?Federal schedule
- Generic for JanuviaFDA Orange Book
- What is Sitagliptin used for?FDA label uses
- Is Sitagliptin a controlled substance?Federal schedule
- Generic for ZituvioFDA Orange Book
- Dipeptidyl Peptidase 4 Inhibitors listFDA drug class
- Januvia Medicare Part D coverageBy plan and state
- NDC 0006-0112Januvia NDC record
- NDC 0006-0221Januvia NDC record
- NDC 0006-0277Januvia NDC record