Medicine
Sulfamethoxazole and Trimethoprim 400 mg/80 mg tablet
Sulfamethoxazole and Trimethoprim 400 mg/80 mg tablet is a generic prescription medicine for oral use, made by 12 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 at 20º to 25ºC (68º to 77ºF), excursions permitted to 15º to 30ºC (59°…
Key facts
- Active ingredient (INN)
- Sulfamethoxazole and Trimethoprim
- Brand
- Sold under the generic name
- Strength
- 400 mg/80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 20 tablets and 25 more
- Manufacturers
- Aurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkAvKAREChartwell RXCronus PharmaRemedyrepackRising Pharma HoldingsVista Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15º to 30ºC (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01EE01 Sulfamethoxazole and Trimethoprim
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 1986
- Identifiers
- RxCUI 198334, 198335DailyMed set ID 29df8839-3dfa-0b2b-c5a3-906db6997b3b, e4a7572f-b372-40eb-963f-919ac100b7a8, 1274cefb-0799-e2e4-e063-6394a90aad02 +9NDC 50268-728, 62135-897, 68071-3579 +9Application ANDA090624, ANDA078060, ANDA076899 +2
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 65862-419-01 | Aurobindo PharmaIndia | 16 February 2010 |
| 500 tablet in 1 bottle | 65862-419-05 | Aurobindo PharmaIndia | 16 February 2010 |
| 20 tablet in 1 bottle | 65862-419-20 | Aurobindo PharmaIndia | 16 February 2010 |
| 1000 tablet in 1 bottle | 65862-419-99 | Aurobindo PharmaIndia | 16 February 2010 |
| 100 tablet in 1 bottle, plastic | 53489-145-01 | Sun Pharmaceutical IndustriesIndia | 25 August 1986 |
| 500 tablet in 1 bottle, plastic | 53489-145-05 | Sun Pharmaceutical IndustriesIndia | 25 August 1986 |
| 50 tablet in 1 bottle | 65162-271-05 | Amneal Pharmaceuticals | 25 February 2010 |
| 100 tablet in 1 bottle | 65162-271-10 | Amneal Pharmaceuticals | 25 February 2010 |
| 1000 tablet in 1 bottle | 65162-271-11 | Amneal Pharmaceuticals | 25 February 2010 |
| 500 tablet in 1 bottle | 65162-271-50 | Amneal Pharmaceuticals | 25 February 2010 |
| 100 tablet in 1 bottle | 53746-271-01 | Amneal Pharmaceuticals of New York | 25 February 2010 |
| 500 tablet in 1 bottle | 53746-271-05 | Amneal Pharmaceuticals of New York | 25 February 2010 |
| 1000 tablet in 1 bottle | 53746-271-10 | Amneal Pharmaceuticals of New York | 25 February 2010 |
| 50 tablet in 1 bottle | 53746-271-50 | Amneal Pharmaceuticals of New York | 25 February 2010 |
| 180 tablet in 1 bottle | 62135-897-18 | Chartwell RX | 11 January 2024 |
| 90 tablet in 1 bottle | 62135-897-90 | Chartwell RX | 11 January 2024 |
| 100 tablet in 1 bottle | 69043-010-01 | Cronus Pharma | 16 February 2010 |
| 500 tablet in 1 bottle | 69043-010-05 | Cronus Pharma | 16 February 2010 |
| 100 tablet in 1 bottle | 57237-232-01 | Rising Pharma Holdings | 16 February 2010 |
| 500 tablet in 1 bottle | 57237-232-05 | Rising Pharma Holdings | 16 February 2010 |
| 100 tablet in 1 bottle | 61971-115-01 | Vista Pharmaceuticals | 6 June 2006 |
| 500 tablet in 1 bottle | 61971-115-05 | Vista Pharmaceuticals | 6 June 2006 |
| 100 tablet in 1 bottle | 42291-758-01 | AvKARE | 5 August 2015 |
| 500 tablet in 1 bottle | 42291-758-50 | AvKARE | 31 October 2016 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-728-15 | AvPAK | 23 September 2014 |
| 100 tablet in 1 bottle | 68071-3579-1 | NuCare Pharmaceuticals,Inc | 28 February 2024 |
| 20 tablet in 1 bottle, plastic | 70518-3454-3 | Remedyrepack | 1 July 2025 |
| 10 tablet in 1 bottle, plastic | 70518-3454-4 | Remedyrepack | 6 August 2025 |
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 30 July 1973 | 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 Sulfamethoxazole and Trimethoprim 400 mg/80 mg tablet.
Other strengths and forms of Sulfamethoxazole and Trimethoprim
Clinical summary
Sulfamethoxazole and Trimethoprim is a fixed-dose combination of a dihydrofolate reductase inhibitor antibacterial and a sulfonamide antimicrobial indicated for prophylactic or prolonged administration in otitis media at any age. MedsAcross supplies Sulfamethoxazole and Trimethoprim 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 Sulfamethoxazole and TrimethoprimFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bactrim prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Sulfamethoxazole and Trimethoprim 400 mg/80 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.