Active ingredient
Indomethacin
85 finished FDA listings contain Indomethacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- INDOMETHACIN, INDOMETHACIN SODIUM
- Dosage forms
- Capsule, Capsule, Extended Release, Injection, Powder, Lyophilized, For Solution, Suppository, Suspension
- Routes
- Intravenous, Oral, Rectal
- Manufacturers / labelers
- 33
- Strengths listed
- 1 mg/ml · 25 mg/1 · 25 mg/5ml · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Indocin, Indomethacin Er
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5781
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018829 | CHARTWELL MOLECULES | 1984-08-06 | 1 |
| NDA 018332 | COSETTE | 1985-10-10 | 1 |
| ANDA 070651 | CHARTWELL MOLECULES | 1986-03-05 | 1 |
| ANDA 073314 | COSETTE | 1992-08-31 | 1 |
| ANDA 079175 | AVANTHI INC | 2009-03-06 | 4 |
| NDA 022536 | FRESENIUS KABI USA | 2010-03-17 | 3 |
| ANDA 091549 | AMNEAL PHARMS | 2010-12-01 | 1 |
| ANDA 091276 | GLENMARK PHARMS LTD | 2010-12-22 | 24 |
| ANDA 091240 | HETERO LABS LTD III | 2011-04-12 | 30 |
| ANDA 201807 | HETERO LABS LTD III | 2012-09-28 | 10 |
| ANDA 203501 | GLENMARK PHARMS LTD | 2017-06-22 | 1 |
| ANDA 216184 | ZYDUS LIFESCIENCES | 2023-08-02 | 3 |
| ANDA 217883 | NOVITIUM PHARMA | 2024-01-12 | 1 |
| ANDA 215899 | HIKMA | 2024-11-19 | 1 |
| ANDA 215399 | AMNEAL | 2025-02-24 | 1 |
| ANDA 216905 | ANNORA PHARMA | 2025-07-03 | 2 |
Official labeling on DailyMed
- INDOMETHACIN (INDOMETHACIN) CAPSULE, EXTENDED RELEASE [SPORTPHARM LLC] · version 4 · 2026-08-19
- INDOMETHACIN CAPSULE [REMEDYREPACK INC.] · version 23 · 2026-07-08
- INDOMETHACIN CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 24 · 2026-06-29
- INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2026-05-28
- INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 17 · 2026-05-28
- INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 15 · 2026-05-25
- INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] · version 103 · 2026-05-25
- INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2026-05-25
- INDOMETHACIN CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 12 · 2026-05-15
- INDOMETHACIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.] · version 6 · 2026-05-15
- INDOMETHACIN CAPSULE [COUPLER LLC] · version 1 · 2026-05-11
- INDOMETHACIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 10 · 2026-05-04
Showing the 12 most recent of 76 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.