Medicine
Benznidazole 12.5 mg tablet
Benznidazole 12.5 mg tablet is a generic prescription medicine for oral use, 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°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Benznidazole
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Exeltis
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep bottle tightly closed and protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01CA02 Benznidazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 March 2018
- Identifiers
- RxCUI 430551, 1993222DailyMed set ID 8983d6a0-f63f-4f8e-bba4-38223f39e29bNDC 0642-7463Application NDA209570
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 0642-7463-12 | Exeltis | 30 March 2018 |
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 29 August 2017 | 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
Other strengths and forms of Benznidazole
Clinical summary
Benznidazole is a prescription medicine indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. It is available as tablets for oral use. MedsAcross supplies Benznidazole 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 BenznidazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Benznidazole prescribing information (Exeltis) · U.S. National Library of Medicine, DailyMed
Need Benznidazole 12.5 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.