Active ingredient
Ethambutol
13 finished FDA listings contain Ethambutol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ETHAMBUTOL HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 100 mg/1 · 400 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4110
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 016320 | KANCHAN HLTHCARE | 1967-11-06 | 6 |
| ANDA 075095 | EPIC PHARMA LLC | 1999-11-30 | 2 |
| ANDA 078939 | LUPIN | 2009-06-17 | 5 |
Official labeling on DailyMed
- ETHAMBUTOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 6 · 2026-08-17
- ETHAMBUTOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 13 · 2026-08-03
- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] · version 9 · 2026-05-07
- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [KANCHAN HEALTHCARE INC] · version 2 · 2025-12-23
- ETHAMBUTOL HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] · version 11 · 2025-11-17
- ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] · version 7 · 2025-09-22
- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] · version 1 · 2025-09-08
- ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] · version 4 · 2023-12-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.