Active ingredient
Nitazoxanide
4 finished FDA listings contain Nitazoxanide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NITAZOXANIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 31819
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 213820 | RISING | 2020-11-27 | 1 |
| ANDA 214844 | ANI PHARMS | 2025-02-03 | 2 |
| ANDA 218701 | ANNORA PHARMA | 2025-04-15 | 1 |
Official labeling on DailyMed
- NITAZOXANIDE TABLET [E5 PHARMA, LLC] · version 3 · 2026-06-22
- NITAZOXANIDE (NITAZOXANIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2025-12-31
- NITAZOXANIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 9 · 2025-11-17
- NITAZOXANIDE TABLET [ANI PHARMACEUTICALS, INC.] · version 1 · 2025-03-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.