Active ingredient
Tolmetin
6 finished FDA listings contain Tolmetin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOLMETIN SODIUM
- Dosage forms
- Capsule, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 200 mg/1 · 400 mg/1 · 600 mg/1
- Brand names in FDA listings
- Tolectin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10636
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 073588 | CHARTWELL RX | 1992-07-31 | 2 |
| ANDA 073393 | RISING | 1993-05-27 | 2 |
| ANDA 074473 | RISING | 1994-08-30 | 2 |
Official labeling on DailyMed
- TOLMETIN SODIUM TABLET [CHARTWELL RX, LLC] · version 1 · 2026-07-21
- TOLMETIN SODIUM TABLET [LIFSA DRUGS LLC] · version 1 · 2026-05-11
- TOLMETIN SODIUM CAPSULE [GALT PHARMACEUTICALS, LLC] · version 1 · 2026-03-23
- TOLECTIN (TOLMETIN SODIUM) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.] · version 3 · 2025-12-31
- TOLMETIN SODIUM TABLET, FILM COATED [ATLAND PHARMACEUTICALS, LLC] · version 3 · 2025-04-02
- TOLMETIN SODIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC] · version 2 · 2025-03-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.