FDA label
What is saxagliptin used for?
The FDA-approved uses of saxagliptin, 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 for saxagliptin (tablet, film coated) lists this use: Monotherapy and Combination Therapy.
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Saxagliptin, tablet, film coated
Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA205994). Cross-references to other label sections are left out.
Monotherapy and Combination Therapy
Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use
Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Source: DailyMed label, set id e286ffd4-c598-47fb-af06-2e15f7e6f99f, version 2, effective January 27, 2026. NDC 68462-726, one of 4 listings for this product.
Saxagliptin, tablet, film coated
Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA205980). Cross-references to other label sections are left out.
Monotherapy and Combination Therapy
Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ].
Limitations of Use
Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Source: DailyMed label, set id 6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78, version 4, effective February 28, 2025. NDC 0378-4705, one of 2 listings for this product.
Questions
What is saxagliptin used for?
The FDA label for saxagliptin (tablet, film coated) lists this use: Monotherapy and Combination Therapy.
What drug class is saxagliptin?
FDA lists saxagliptin 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.