Active ingredient
Fidaxomicin
6 finished FDA listings contain Fidaxomicin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FIDAXOMICIN
- Dosage forms
- Granule, For Suspension, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 200 mg/1 · 200 mg/5ml
- Brand names in FDA listings
- Dificid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1111103
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 201699 | CUBIST PHARMS LLC | 2011-05-27 | 1 |
| NDA 213138 | CUBIST PHARMS LLC | 2020-01-24 | 1 |
| ANDA 208443 | ACTAVIS LABS FL | 2024-01-16 | 1 |
| ANDA 220374 | TORRENT | 2026-01-27 | 1 |
| ANDA 219559 | APOTEX | 2026-02-02 | 1 |
| ANDA 220465 | SANDOZ | 2026-08-13 | 1 |
Official labeling on DailyMed
- FIDAXOMICIN TABLET, FILM COATED [SANDOZ INC] · version 1 · 2026-08-28
- FIDAXOMICIN TABLET, FILM COATED [APOTEX CORP.] · version 2 · 2026-02-16
- FIDAXOMICIN TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] · version 5 · 2026-02-03
- DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] · version 21 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.