FDA label
What is indomethacin used for?
The FDA-approved uses of indomethacin, 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: “Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease; Moderate to severe ankylosing spondylitis; Moderate to severe osteoarthritis; Acute painful shoulder (bursitis and/or tendinitis); Acute gouty arthritis.”
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Indomethacin, capsule
Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA091276). Cross-references to other label sections are left out.
Indomethacin capsules are indicated for:
- Moderate to severe rheumatoid arthritis including acute flares of chronic disease
- Moderate to severe ankylosing spondylitis
- Moderate to severe osteoarthritis
- Acute painful shoulder (bursitis and/or tendinitis)
- Acute gouty arthritis
Source: DailyMed label, set id f7ed39e2-5431-4e47-935c-c7441d058f94, version 13, effective December 19, 2025. NDC 68462-302, one of 56 listings for this product.
Indomethacin, capsule, extended release
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA201807). Cross-references to other label sections are left out.
Indomethacin extended-release capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis)
Source: DailyMed label, set id 12f62bae-5fc0-4f8d-a8b4-446524bd53d1, version 7, effective May 8, 2025. NDC 31722-565, one of 16 listings for this product.
Indomethacin, suppository
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA216905). Cross-references to other label sections are left out.
Indomethacin Suppository is indicated for:
- Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis
Source: DailyMed label, set id c81343f2-5ef5-4635-9b94-5ac8d72aa61e, version 1, effective September 3, 2025. NDC 31722-051, one of 8 listings for this product.
Questions
What is indomethacin used for?
The FDA label says: “Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease; Moderate to severe ankylosing spondylitis; Moderate to severe osteoarthritis; Acute painful shoulder (bursitis and/or tendinitis); Acute gouty arthritis.”
What drug class is indomethacin?
FDA lists indomethacin in the Nonsteroidal Anti-inflammatory Drug 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.