Medicine
Tindazole 500 mg tablet
Tindazole 500 mg tablet is a prescription medicine containing Tinidazole for oral use, marketed by Rising Pharma Holdings, 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 at controlled room temperature 20-25° C (68-77° F), excursions permitted…
Key facts
- Active ingredient (INN)
- Tinidazole
- Brand
- Tindazole
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 12 tablets, 8 tablets
- Marketing authorisation holder
- Rising Pharma Holdings
- Manufacturers
- Rising Pharma HoldingsRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20-25° C (68-77° F), excursions permitted to 15-30° C (59-86° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XD02 Tinidazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 October 2013
- Identifiers
- RxCUI 199519, 477234DailyMed set ID 32167dd7-5d37-457b-9b00-cd735de6b060, 45fa3ebd-52da-4987-82a1-4a64f99785a7NDC 64980-427, 70518-4172Application ANDA202489
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 12 tablet, film coated in 1 bottle, plastic | 64980-427-12 | Rising Pharma Holdings | 9 October 2013 |
| 8 tablet, film coated in 1 bottle, plastic | 70518-4172-0 | Remedyrepack | 30 August 2024 |
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 17 May 2004 | 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
Alternatives
Other makers and brands of Tinidazole 500 mg tablet.
Other strengths and forms of Tinidazole
Clinical summary
Tinidazole is a nitroimidazole antimicrobial indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Tinidazole 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 TinidazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tinidazole prescribing information (BioComp Pharma) · U.S. National Library of Medicine, DailyMed
Need Tindazole 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.