Active ingredient
Sulindac
14 finished FDA listings contain Sulindac as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SULINDAC
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 150 mg/1 · 200 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10237
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 |
|---|---|---|---|
| ANDA 071795 | WATSON LABS | 1988-03-03 | 2 |
| ANDA 071891 | WATSON LABS | 1988-03-03 | 1 |
| ANDA 072711 | EPIC PHARMA | 1991-03-25 | 4 |
| ANDA 072051 | SUN PHARM INDUSTRIES | 1991-04-17 | 3 |
| ANDA 072050 | SUN PHARM INDUSTRIES | 1991-04-17 | 2 |
Official labeling on DailyMed
- SULINDAC TABLET [A-S MEDICATION SOLUTIONS] · version 16 · 2026-05-11
- SULINDAC TABLET [A-S MEDICATION SOLUTIONS] · version 11 · 2026-03-20
- SULINDAC TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] · version 9 · 2025-12-12
- SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] · version 22 · 2025-11-17
- SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] · version 22 · 2025-04-07
- SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2025-03-24
- SULINDAC TABLET [EPIC PHARMA, LLC] · version 19 · 2024-12-23
- SULINDAC TABLET [ACTAVIS PHARMA, INC.] · version 13 · 2024-12-10
- SULINDAC TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 16 · 2024-10-25
- SULINDAC TABLET [PROFICIENT RX LP] · version 1 · 2022-03-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.