Medicine
Sulfamethoxazole and Trimethoprim 200 mg/40 mg per 5 mL oral suspension
Sulfamethoxazole and Trimethoprim 200 mg/40 mg per 5 mL oral suspension is a generic prescription medicine for oral use, made by 11 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) and protect from light.
Key facts
- Active ingredient (INN)
- Sulfamethoxazole and Trimethoprim
- Brand
- Sold under the generic name
- Strength
- 200 mg/40 mg per 5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 100 mL, 473 mL, 50 mL and 16 more
- Manufacturers
- Aurobindo PharmaIndiaAtlantic BiologicalsChartwell RXA-S Medication SolutionsAmerican Health PackagingANI PharmaceuticalsChartwell Governmental & Specialty RXKesin PharmaPAI PharmaPrasco Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF) and protect from light.
- 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
- 24 January 2007
- Identifiers
- RxCUI 313134DailyMed set ID acc3df02-1e99-46e6-8a31-9b26261c6daa, a6182855-6287-45e9-b6b4-7b57efc9c76e, 2a5173ba-047d-4a80-81fb-7154265ae3d1 +8NDC 17856-0496, 65862-496, 68999-873 +9Application ANDA091348, ANDA077785, ANDA214330 +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 mL in 1 bottle | 65862-496-01 | Aurobindo PharmaIndia | 8 June 2010 |
| 473 mL in 1 bottle | 65862-496-47 | Aurobindo PharmaIndia | 8 June 2010 |
| 50 mL in 1 bottle | 65862-496-50 | Aurobindo PharmaIndia | 8 June 2010 |
| 473 mL in 1 bottle | 62135-749-47 | Chartwell RX | 11 October 2023 |
| 2 tray in 1 box / 10 cup in 1 tray / 20 mL in 1 cup | 62135-873-24 | Chartwell RX | 30 May 2024 |
| 473 mL in 1 bottle | 70954-258-10 | ANI Pharmaceuticals | 8 February 2022 |
| 2 tray in 1 box / 10 cup in 1 tray / 20 mL in 1 cup | 68999-873-24 | Chartwell Governmental & Specialty RX | 18 February 2026 |
| 10 cup, unit-dose in 1 tray / 20 mL in 1 cup, unit-dose | 0121-0853-20 | PAI Pharma | 5 August 2024 |
| 473 mL in 1 bottle | 50090-0525-0 | A-S Medication Solutions | 29 June 2016 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 20 mL in 1 cup, unit-dose | 60687-442-75 | American Health Packaging | 7 November 2024 |
| 72 cup, unit-dose in 1 box / 5 mL in 1 cup, unit-dose | 17856-0496-4 | Atlantic Biologicals | 12 April 2024 |
| 50 cup, unit-dose in 1 box / 20 mL in 1 cup, unit-dose | 17856-0496-5 | Atlantic Biologicals | 12 April 2024 |
| 72 cup, unit-dose in 1 box / 10 mL in 1 cup, unit-dose | 17856-0496-6 | Atlantic Biologicals | 12 April 2024 |
| 48 syringe in 1 case / 5 mL in 1 syringe | 17856-0496-7 | Atlantic Biologicals | 5 August 2026 |
| 48 syringe in 1 case / 10 mL in 1 syringe | 17856-0496-8 | Atlantic Biologicals | 5 August 2026 |
| 48 cup, unit-dose in 1 case / 20 mL in 1 cup, unit-dose | 17856-0496-9 | Atlantic Biologicals | 25 August 2026 |
| 40 cup, unit-dose in 1 carton / 20 mL in 1 cup, unit-dose | 81033-012-40 | Kesin Pharma | 4 April 2025 |
| 473 mL in 1 bottle, plastic | 66993-727-57 | Prasco Laboratories | 5 July 2022 |
| 473 mL in 1 bottle | 68788-8607-4 | Preferred Pharmaceuticals | 14 March 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 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 200 mg/40 mg per 5 mL oral suspension.
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 200 mg/40 mg per 5 mL oral suspension 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.