Is Sulfamethoxazole + Trimethoprim registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Sulfamethoxazole + Trimethoprim, including BACTRIM FORTE TAB (800,160 mg/ml,mg/ml, Tablet, SAR 23.30); BACTRIM SUSP (40,8 mg/ml,mg/ml, Oral suspension, SAR 19.00); BALKATRIN SUSP (40,8 mg/ml,mg/ml, Syrup, SAR 6.05); BALKATRIN TAB (400,80 mg,mg, Tablet, SAR 8.90); TRIMOL SUSP (40,8 mg/ml,mg/ml, Syrup, SAR 8.55).

Is Sulfamethoxazole + Trimethoprim approved by the US FDA?

Drugs@FDA lists 72 application product lines for Sulfamethoxazole + Trimethoprim, including BACTRIM (Prescription); BACTRIM DS (Prescription); SULFATRIM PEDIATRIC (Prescription); SULFAMETHOXAZOLE AND TRIMETHOPRIM (Prescription); SULFAMETHOXAZOLE AND TRIMETHOPRIM (Prescription).

Is Sulfamethoxazole + Trimethoprim on the WHO Model List of Essential Medicines?

Yes — 6.5.4. Antipneumocystosis and antitoxoplasmosis medicines (core list): Pneumocystosis.

Active substances

Sulfamethoxazole + Trimethoprim

SFDA 34
US FDA 72
Health Canada 7
US price lines 3
NHS prices 5
WHO EML 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BACTRIM FORTE TAB	800,160 mg/ml,mg/ml	Tablet · Oral use	10 Blister	SAR 23.30	Generic · Prescription	SPIMACO ADDWAEIH	Valid
BACTRIM SUSP	40,8 mg/ml,mg/ml	Oral suspension · Oral use	1 Bottle	SAR 19.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
BALKATRIN SUSP	40,8 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 6.05	Generic · Prescription	APM	Valid
BALKATRIN TAB	400,80 mg,mg	Tablet · Oral use	20 Blister	SAR 8.90	Generic · Prescription	APM	Valid
TRIMOL SUSP	40,8 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 8.55	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
TRIMOL SUSP.	40,8 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 17.10	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
BACTRIM AMP 5ML I.V	80, 16 mg/ml	Solution · Intravenous use	50 Ampoule	SAR 384.35	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
BACTRIM PED SYRUP (200+40mg-5ML)	40, 8 mg/ml	Syrup · Oral use	1 Bottle	SAR 13.15	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
BACTRIM PED SYRUP (200+40mg-5ML)	40, 8 mg/ml	Syrup · Oral use	1 Bottle	SAR 17.05	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
BACTRIM TAB ADULT	400, 80 mg	Tablet · Oral use	20 Blister	SAR 23.55	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
BALKATRIN FORTE(160+800) TAB	800, 160 mg	Tablet · Oral use	10 Blister	SAR 5.15	Generic · Prescription	APM	Withdrawn by MAH · Not Marketed
BALKATRIN SUSP( 200+40MG-5ML)	40, 8 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.80	Generic · Prescription	APM	Withdrawn by MAH · Not Marketed
CHEMOTRIM TABS	400, 80 mg	Tablet · Oral use	20 Blister	SAR 7.00	Generic · Prescription	KAHIRA EYGEPT	Withdrawn by regulatory authority · Not Marketed
NORTRIME SUSP (200+40MG-5ML)	40, 8 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 2.60	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
NORTRIME TAB	400, 80 mg	Tablet · Oral use	20 Blister	SAR 5.20	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
SEPTAZOLE TAB (400-80)	400, 80 mg	Tablet · Oral use	20 Blister	SAR 7.00	Generic · Prescription	ALEXANDRIA CO.	Withdrawn by regulatory authority · Not Marketed
SEPTRIN	400, 80 mg	Tablet · Oral use	20 Blister	SAR 18.40	Generic · Prescription	GLAXO SAUDI ARABIA	Withdrawn by regulatory authority · Not Marketed
SEPTRIN 240MG SUSP	40, 8 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 16.85	Generic · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
SEPTRIN 240MG SUSP	40, 8 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 16.85	Generic · Prescription	ASPEN	Withdrawn by MAH · Not Marketed
SEPTRIN 480MG TABLET	400, 80 mg	Tablet · Oral use	20 Blister	SAR 18.20	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
SEPTRIN 480MG TABLET	400, 80 mg	Tablet · Oral use	20 Blister	SAR 18.20	NCE · Prescription	ASPEN	Withdrawn by MAH · Not Marketed
SEPTRIN DOUBLE STRENGTH TAB	800, 160 mg	Tablet · Oral use	10 Blister	SAR 16.65	Generic · Prescription	GLAXOWELLCOME	Withdrawn by regulatory authority · Not Marketed
SEPTRIN DOUPLE STRENGTH TAB	800, 160 mg	Tablet · Oral use	10 Blister	SAR 16.50	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
SEPTRIN DOUPLE STRENGTH TAB	800, 160 mg	Tablet · Oral use	10 Blister	SAR 16.50	NCE · Prescription	ASPEN	Withdrawn by MAH · Not Marketed
SEPTRIN I.M INJ 3ML	266.7,53.3 mg/ml,mg/ml	Solution · Intravenous use	10 Ampoule	SAR 110.25	Generic · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed

9 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); ACUTE PYELONEPHRITIS; ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; ADULT ACUTE MYELOID LEUKAEMIA (AML); ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - OTHER SALMONELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - SHIGELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - TYPHOID AND PARATYPHOID FEVERS; BLASTOCYSTIS SPP, CYCLOSPORIASIS, CYSTOISOSPORIASIS; BREAST CANCER MET. HORMONAL-SUPPORTIVE CARE; BRUCELLOSIS; BURKITT`S LYMPHOMA; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; HODGKIN'S LYMPHOMA; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; HUMAN IMMUNODEFICIENCY VIRUS; INFECTIOUS UVEITIS; INTRA-ABDOMINAL INFECTIONS; LICHEN PLANUS; LOWER URINARY TRACT INFECTIONS; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; OSTEOMYELITIS; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; PEDIATRIC B-CELL LYMPHOMA; PERITONITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); RENAL TRANSPLANT; SINUSITIS; T-CELL LYMPHOMA-RENAL TOXICITY; TRAVEL RELATED INFECTIONS-TREATMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BACTRIM	400MG;80MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	30 Jul 1973
BACTRIM DS	800MG;160MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	30 Jul 1973
SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	suspension · oral	PHARM ASSOC	Prescription	7 Jan 1983
SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG; 400MG;80MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	25 Aug 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIM	80MG/ML;16MG/ML	injectable · injection	TEVA PHARMS USA	Prescription	31 Oct 1991
SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG; 800MG;160MG	tablet · oral	AMNEAL PHARMS NY	Prescription	27 Jan 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG; 800MG;160MG	tablet · oral	VISTA PHARMS	Prescription	7 Oct 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	suspension · oral	PRASCO	Prescription	13 Nov 2006
SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	suspension · oral	CHARTWELL MOLECULAR	Prescription	24 Jan 2007
SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG; 400MG;80MG	tablet · oral	CHARTWELL MOLECULES	Prescription	25 Jan 2007
SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG; 800MG;160MG	tablet · oral	AUROBINDO PHARMA	Prescription	16 Feb 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	suspension · oral	AUROBINDO PHARMA	Prescription	8 Jun 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG; 400MG;80MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	22 Dec 2010
SULFAMETHOXAZOLE AND TRIMETHOPRIM	80MG/ML;16MG/ML	injectable · injection	PHARMOBEDIENT	Prescription	30 Aug 2017
SULFAMETHOXAZOLE AND TRIMETHOPRIM	80MG/ML;16MG/ML	injectable · injection	SOMERSET	Prescription	26 Jun 2019
SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	suspension · oral	NOVITIUM PHARMA	Prescription	8 Feb 2022
SEPTRA	400MG;80MG	tablet · oral	MONARCH PHARMS	Discontinued	30 Jul 1973
SEPTRA DS	800MG;160MG	tablet · oral	MONARCH PHARMS	Discontinued	30 Jul 1973
BACTRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	SUN PHARM INDUSTRIES	Discontinued	15 Apr 1975
BACTRIM PEDIATRIC	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	SUN PHARM INDUSTRIES	Discontinued	15 Apr 1975
SEPTRA	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	MONARCH PHARMS	Discontinued	31 May 1975
SEPTRA GRAPE	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	MONARCH PHARMS	Discontinued	31 May 1975
SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG; 800MG;160MG	tablet · oral	TEVA	Discontinued	19 May 1981
BACTRIM	80MG/ML;16MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	SUN PHARM INDS INC	Discontinued	23 Jun 1981
SEPTRA	80MG/ML;16MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	MONARCH PHARMS	Discontinued	23 Jun 1981

47 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SEPTRA INJECTION	00550086	16 MG / ML; 80 MG / ML	SOLUTION · INTRAVENOUS	ASPEN PHARMACARE CANADA INC.
SEPTRA PEDIATRIC ORAL SUSPENSION	02563495	8 MG / ML; 40 MG / ML	SUSPENSION · ORAL	ASPEN PHARMACARE CANADA INC.
SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP	02525917	16 MG / ML; 80 MG / ML	SOLUTION · INTRAVENOUS	AURO PHARMA INC
SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP	02534746	80 MG / ML; 16 MG / ML	SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
SULFATRIM	00445274	80 MG; 400 MG	TABLET · ORAL	AA PHARMA INC
SULFATRIM DS	00445282	160 MG; 800 MG	TABLET · ORAL	AA PHARMA INC
SULFATRIM PEDIATRIC	00445266	100 MG; 20 MG	TABLET · ORAL	AA PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SULFAMETHOXAZOLE-TMP DS TABLET	$0.04481	per EA	23 Sep 2026
US NADAC	SULFAMETHOXAZOLE-TMP SS TABLET	$0.03948	per EA	23 Sep 2026
US NADAC	SULFAMETHOXAZOLE-TMP SUSP	$0.05553	per ML	23 Sep 2026
NHS Drug Tariff	Co-trimoxazole 160mg/800mg tablets	£10.44	100 tablet	1 Oct 2026
NHS Drug Tariff	Co-trimoxazole 40mg/200mg/5ml oral suspension sugar free	£17.53	100 ml	1 Oct 2026
NHS Drug Tariff	Co-trimoxazole 80mg/400mg tablets	£1.77	28 tablet	1 Oct 2026
NHS Drug Tariff	Co-trimoxazole 80mg/400mg/5ml oral suspension	£18.11	100 ml	1 Oct 2026
NHS Drug Tariff	Co-trimoxazole 80mg/400mg/5ml solution for infusion ampoules	£47.15	10 ampoule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

6.5.4. Antipneumocystosis and antitoxoplasmosis medicines · core
Pneumocystosis
Parenteral > General injections > IV: 80 mg + 16 mg per mL in 5 mL ampoule; 80 mg + 16 mg per mL in 10 mL ampoule | Oral > Liquid: 200 mg + 40 mg per 5 mL oral liquid (EMLc) | Oral > Solid: 100 mg + 20 mg tablet (EMLc); 400 mg + 80 mg tablet (EMLc); 800 mg + 160 mg tablet | Oral > Solid > dispersible tablet: 100 mg + 20 mg (EMLc)
6.2.1. Access group antibiotics · core
First choice: Infectious cystitis; Second choice: Infectious gastroenteritis or colitis without specification of infectious agent
Parenteral > General injections > IV: 80 mg + 16 mg per mL in 10 mL ampoule; 80 mg + 16 mg per mL in 5 mL ampoule | Oral > Liquid: 200 mg + 40 mg per 5 mL oral liquid | Oral > Solid: 100 mg + 20 mg tablet; 400 mg + 80 mg tablet; 800 mg + 160 mg tablet (EML) | Oral > Solid > dispersible tablet: 100 mg + 20 mg | Oral > Solid > dispersible tablet: 100 mg + 20 mg (EMLc)

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.