FDA label
What is balsalazide used for?
The FDA-approved uses of balsalazide, 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: “Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted balsalazide?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Balsalazide Disodium, capsule
Indications and Usage, quoted from the label by Apotex Corp. (ANDA077883). Cross-references to other label sections are left out.
Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Limitations of Use
Safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.
Source: DailyMed label, set id f12ffa32-d14b-e9d9-e957-2ef08b64e8b4, version 15, effective September 9, 2026. NDC 60505-2575, one of 9 listings for this product.
Questions
What is balsalazide used for?
The FDA label says: “Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.”
What drug class is balsalazide?
FDA lists balsalazide 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.