Medicine
Nitazoxanide 500 mg tablet
Nitazoxanide 500 mg tablet is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store the tablets at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to…
Key facts
- Active ingredient (INN)
- Nitazoxanide
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle, 6 tablets, 30 tablets and 6 more
- Manufacturers
- Camber PharmaceuticalsIndiaRising Pharma HoldingsANI Pharmaceuticalse5 Pharma
- Origin register
- US FDA, United States
- Storage
- Store the tablets at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01AX11 Nitazoxanide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 November 2020
- Identifiers
- RxCUI 427163DailyMed set ID c0dc0656-3c46-43f9-adea-5285c522cef8, 295011e1-f919-4e5a-b9e7-4c784f623a86, 40a7cc30-76cd-49fe-965a-7823c4140d0f +1NDC 64980-526, 31722-100, 13517-135 +1Application ANDA213820, ANDA218701, ANDA214844
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 31722-100-30 | Camber PharmaceuticalsIndia | 15 April 2025 |
| 1 bottle in 1 carton / 12 tablet, film coated in 1 bottle | 31722-100-31 | Camber PharmaceuticalsIndia | 15 April 2025 |
| 1 bottle in 1 carton / 6 tablet, film coated in 1 bottle | 31722-100-32 | Camber PharmaceuticalsIndia | 15 April 2025 |
| 6 tablet in 1 bottle | 70954-934-10 | ANI Pharmaceuticals | 5 March 2025 |
| 6 tablet in 1 bottle | 13517-135-06 | e5 Pharma | 1 June 2026 |
| 30 tablet, film coated in 1 bottle | 64980-526-03 | Rising Pharma Holdings | 27 November 2020 |
| 12 tablet, film coated in 1 bottle | 64980-526-21 | Rising Pharma Holdings | 27 November 2020 |
| 6 tablet, film coated in 1 bottle | 64980-526-60 | Rising Pharma Holdings | 27 November 2020 |
| 18 tablet, film coated in 1 bottle | 64980-526-81 | Rising Pharma Holdings | 27 November 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 22 November 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Nitazoxanide is an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. It is available as tablets for oral use. MedsAcross supplies Nitazoxanide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about NitazoxanideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nitazoxanide prescribing information (Camber Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Nitazoxanide 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.