FDA label
What is mesalamine used for?
The FDA-approved uses of mesalamine, 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: “Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.”
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Mesalamine, tablet, delayed release
Indications and Usage, quoted from the label by Zydus Pharmaceuticals USA Inc. (ANDA203286). Cross-references to other label sections are left out.
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.
Limitations of Use:
Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established.
Source: DailyMed label, set id ad8c7930-92e2-4372-a874-da22b9ae333e, version 9, effective July 14, 2026. NDC 68382-435, one of 20 listings for this product.
Mesalamine, capsule, extended release
Indications and Usage, quoted from the label by Sandoz Inc (ANDA219997). Cross-references to other label sections are left out.
Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.
Source: DailyMed label, set id 47b5d1ee-b439-4ccb-9b01-c0875ccd748a, version 3, effective June 30, 2026. NDC 0781-2791, one of 16 listings for this product.
Mesalamine, suppository
Indications and Usage, quoted from the label by Actavis Pharma, Inc. (ANDA205654). Cross-references to other label sections are left out.
Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Source: DailyMed label, set id 73317da3-cba0-4106-9e88-79b0e2f642af, version 9, effective February 24, 2026. NDC 0472-1915, one of 10 listings for this product.
Questions
What is mesalamine used for?
The FDA label says: “Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.”
What drug class is mesalamine?
FDA lists mesalamine in the Aminosalicylate 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.
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