FDA label
What is Janumet used for?
Janumet contains sitagliptin and metformin. 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: “JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
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Janumet, tablet, film coated, extended release
Indications and Usage, quoted from the label by Merck Sharp & Dohme LLC (NDA202270). Cross-references to other label sections are left out.
JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
JANUMET XR should not be used in patients with type 1 diabetes mellitus.JANUMET XR 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 JANUMET XR.
Source: DailyMed label, set id 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50, version 44, effective August 11, 2026. NDC 0006-0078, one of 4 listings for this product.
Janumet, tablet, film coated
Indications and Usage, quoted from the label by Merck Sharp & Dohme LLC (NDA022044). Cross-references to other label sections are left out.
JANUMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
JANUMET should not be used in patients with type 1 diabetes mellitus.
JANUMET 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 JANUMET.
Source: DailyMed label, set id d19c7ed0-ad5c-426e-b2df-722508f97d67, version 61, effective August 11, 2026. NDC 0006-0575, one of 4 listings for this product.
Questions
What is Janumet used for?
The FDA label says: “JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
What drug class is Janumet?
FDA lists sitagliptin and metformin in the Biguanide and 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 Janumet
- Is Janumet a controlled substance?Federal schedule
- Generic for JanumetFDA Orange Book
- Generic for Janumet XRFDA Orange Book
- Generic for Zituvimet XRFDA Orange Book
- Generic for ZituvimetFDA Orange Book
- Biguanides listFDA drug class
- Dipeptidyl Peptidase 4 Inhibitors listFDA drug class
- Janumet Medicare Part D coverageBy plan and state
- NDC 0006-0078Janumet NDC record
- NDC 0006-0080Janumet NDC record
- NDC 0006-0081Janumet NDC record