Active ingredient
Trimethoprim
5 finished FDA listings contain Trimethoprim as their only active ingredient; 118 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TRIMETHOPRIM, TRIMETHOPRIM SULFATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10829
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 018679 | DR REDDYS LABS SA | 1982-07-30 | 1 |
| ANDA 091437 | NOVEL LABS INC | 2011-06-15 | 2 |
| ANDA 216393 | NOVITIUM PHARMA | 2022-10-28 | 2 |
Official labeling on DailyMed
- TRIMETHOPRIM TABLET [LUPIN PHARMACEUTICALS,INC.] · version 6 · 2024-12-04
- TRIMETHOPRIM TABLET [DR. REDDY'S LABRATORIES INC.] · version 1 · 2024-01-30
- TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2023-03-21
- TRIMETHOPRIM TABLET [NOVITIUM PHARMA LLC] · version 1 · 2022-11-04
- TRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.] · version 3 · 2017-11-30
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.