FDA label
What is Pentasa used for?
Pentasa contains mesalamine. 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: “PENTASA is indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.”
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Pentasa, capsule
Indications and Usage, quoted from the label by Takeda Pharmaceuticals America, Inc. (NDA020049). Cross-references to other label sections are left out.
PENTASA is 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 e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606, version 42, effective January 15, 2025. NDC 54092-189, one of 2 listings for this product.
Questions
What is Pentasa used for?
The FDA label says: “PENTASA is indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.”
What drug class is Pentasa?
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.
More on Pentasa
- Is Pentasa a controlled substance?Federal schedule
- Generic for PentasaFDA Orange Book
- What is Mesalamine used for?FDA label uses
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- Aminosalicylates listFDA drug class
- Pentasa Medicare Part D coverageBy plan and state
- NDC 54092-189Pentasa NDC record
- NDC 54092-191Pentasa NDC record