Medicine
Sulfamethox-TMP DS 800 mg/160 mg tablet
Sulfamethox-TMP DS 800 mg/160 mg tablet is a prescription medicine containing Sulfamethoxazole and Trimethoprim for oral use, marketed by PharmPak, 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 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Sulfamethoxazole and Trimethoprim
- Brand
- Sulfamethox-TMP DS
- Strength
- 800 mg/160 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle and 1 more
- Marketing authorisation holder
- PharmPak
- Manufacturer
- PharmPak
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 11 July 2019
- Identifiers
- RxCUI 198335DailyMed set ID ede74118-32c5-4f52-9823-509538e674c8NDC 54348-625Application ANDA076899
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 box / 6 tablet in 1 bottle | 54348-625-06 | PharmPak | 11 July 2019 |
| 1 bottle in 1 box / 10 tablet in 1 bottle | 54348-625-10 | PharmPak | 11 July 2019 |
| 1 bottle in 1 box / 14 tablet in 1 bottle | 54348-625-14 | PharmPak | 11 July 2019 |
| 1 bottle in 1 box / 20 tablet in 1 bottle | 54348-625-20 | PharmPak | 11 July 2019 |
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 800 mg/160 mg tablet.
- Sulfamethoxazole and Trimethoprim 800 mg/160 mg tabletAvailable on request—US FDA40 packs
- Sulfamethoxazole and Trimethoprim DS 800 mg/160 mg tabletAvailable on requestAdvanced Rx Pharmacy of TennesseeUS FDA5 packs
- Bactrim DS 800 mg/160 mg tabletAvailable on requestSun Pharmaceutical IndustriesIndiaUS FDA1 pack
- Sulfamethoxazole and Trimethoprim DS 800 mg/160 mg tabletAvailable on requestAdvanced Rx Pharmacy of TennesseeUS FDA1 pack
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 Sulfamethox-TMP DS 800 mg/160 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.