Active substance
Nitazoxanide
- US FDA 6
- US price lines 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ALINIA | 500MG | tablet · oral | ROMARK | Prescription | 16 Jun 2005 |
| NITAZOXANIDE | 500MG | tablet · oral | RISING | Prescription | 27 Nov 2020 |
| NITAZOXANIDE | 500MG | tablet · oral | ANI PHARMS | Prescription | 3 Feb 2025 |
| NITAZOXANIDE | 500MG | tablet · oral | ANNORA PHARMA | Prescription | 15 Apr 2025 |
| ALINIA | 100MG/5ML | for suspension · oral | ROMARK | Discontinued | 22 Nov 2002 |
| ALINIA | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ROMARK | Discontinued | 21 Jul 2004 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NITAZOXANIDE 500 MG TABLET | $82.19697 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 16 Dec 2021 ALINIA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Jul 2016 ALINIA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.