Medicine
Sulfamethoxazole and Trimethoprim 400 mg/80 mg per 5 mL injection
Sulfamethoxazole and Trimethoprim 400 mg/80 mg per 5 mL injection is a generic prescription medicine for intravenous use, made by 2 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
DO NOT REFRIGERATE. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Sulfamethoxazole and Trimethoprim
- Brand
- Sold under the generic name
- Strength
- 400 mg/80 mg per 5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 5 mL
- Manufacturers
- Somerset TherapeuticsTeva Parenteral Medicines
- Origin register
- US FDA, United States
- Storage
- DO NOT REFRIGERATE. 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
- 1 November 1991
- Identifiers
- RxCUI 313137, 1809083DailyMed set ID b89b5502-ce87-45a6-a43c-9891da3cfca4, ebb570bb-6e5e-489e-875c-9e7b3a6d716aNDC 0703-9503, 70069-361Application ANDA073303, ANDA212231
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 |
|---|---|---|---|
| 10 vial in 1 carton / 5 mL in 1 vial | 70069-361-10 | Somerset Therapeutics | 29 August 2019 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0703-9503-03 | Teva Parenteral Medicines | 1 November 1991 |
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
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 per 5 mL injection 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.