Active substance
Sulfasalazine
- SFDA 2
- US FDA 17
- Health Canada 5
- US price lines 2
- NHS prices 4
- WHO EML 2
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| SALAZOPYRIN-EN TAB 500MG | 500 mg | Tablet · Oral use | 100 Bottle | SAR 28.35 | NCE · Prescription | Pfizer AB | Valid |
| SALAZOPYRIN-EN TAB 500MG | 500 mg | Tablet · Oral use | 100 Tablet Container | SAR 28.35 | NCE · Prescription | Advanced Medical Optics, Inc. (AMO) | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANKYLOSING SPONDYLITIS; CROHN'S DISEASE; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LICHEN PLANUS; NON-INFECTIOUS UVEITIS; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS; SJOGREN'S SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AZULFIDINE | 500MG | tablet · oral | PFIZER | Prescription | 20 Jun 1950 |
| AZULFIDINE EN-TABS | 500MG | tablet, delayed release · oral | PFIZER | Prescription | 20 Jun 1950 |
| SULFASALAZINE | 500MG | tablet · oral | CHARTWELL | Prescription | 12 Nov 1973 |
| SULFASALAZINE | 500MG | tablet · oral | WATSON LABS | Prescription | 21 Oct 1977 |
| AZULFIDINE | 500MG | tablet · oral | PHARMACIA AND UPJOHN | Prescription | 17 Oct 1996 |
| AZULFIDINE EN-TABS | 500MG | tablet · oral | PHARMACIA UPJOHN | Prescription | 18 Aug 2000 |
| SULFASALAZINE | 500MG | tablet · oral | NUVO PHARMS INC | Prescription | 11 Jan 2002 |
| SULFASALAZINE | 500MG | tablet, delayed release · oral | NUVO PHARMS INC | Prescription | 11 Jan 2002 |
| SULFASALAZINE | 500MG | tablet · oral | RISING | Prescription | 4 Nov 2025 |
| S.A.S.-500 | 500MG | tablet · oral | SOLVAY | Discontinued | 9 Apr 1974 |
| SULFASALAZINE | 500MG | tablet · oral | WATSON LABS | Discontinued | 12 May 1976 |
| AZULFIDINE | 250MG/5ML | suspension · oral | PHARMACIA AND UPJOHN | Discontinued | 29 Dec 1980 |
| SULFASALAZINE | 500MG | tablet · oral | WATSON LABS | Discontinued | 2 Apr 1981 |
| SULFASALAZINE | 500MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 19 Oct 1987 |
| SULFASALAZINE | 500MG | tablet · oral | EPIC PHARMA LLC | Discontinued | 16 Sep 1994 |
| SULFASALAZINE | 500MG | tablet, delayed release · oral | WATSON LABS | Discontinued | |
| SULFASALAZINE | 500MG | tablet · oral | SUPERPHARM | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JAMP SULFASALAZINE | 02544652 | 500 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PMS-SULFASALAZINE 500MG/TAB USP | 00598461 | 500 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-SULFASALAZINE-E.C. TAB 500MG | 00598488 | 500 MG | TABLET (ENTERIC-COATED) · ORAL | PHARMASCIENCE INC |
| SALAZOPYRIN EN-TABS 500 MG | 02064472 | 500 MG | TABLET (ENTERIC-COATED) · ORAL | PFIZER CANADA ULC |
| SALAZOPYRIN TAB 500MG | 02064480 | 500 MG | TABLET · ORAL | PFIZER CANADA ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SULFASALAZINE 500 MG TABLET | $0.1991 | per EA | 23 Sep 2026 |
| US NADAC | SULFASALAZINE DR 500 MG TAB | $0.28592 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Sulfasalazine 250mg/5ml oral suspension sugar free | £157.01 | 500 ml | 1 Oct 2026 |
| NHS Drug Tariff | Sulfasalazine 500mg gastro-resistant tablets | £9.61 | 112 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sulfasalazine 500mg suppositories | £3.30 | 10 suppository | 1 Oct 2026 |
| NHS Drug Tariff | Sulfasalazine 500mg tablets | £7.82 | 112 tablet | 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)
- 29.2. Disease-modifying anti-rheumatic drugs (DMARDs) · complementary
Rheumatoid arthritis, serology unspecified
Oral > Solid: 500 mg - 17.3. Anti-inflammatory medicines · core
Crohn disease site; Ulcerative colitis
Oral > Solid: 500 mg | Local > Rectal > Suppository: 500 mg | Local > Rectal > Retention enema: 3 g per 100 mL
Safety signals and safety-related labeling changes
- EMA PRAC 30 Oct 2025 PRAC signal: Idiopathic intracranial hypertension (pseudotumor cerebri)
Action for MAH: update of the product information: No - EMA PRAC 10 Jul 2025 PRAC signal: Idiopathic intracranial hypertension (pseudotumor cerebri)
Action for MAH: update of the product information: No - US FDA 16 Nov 2022 AZULFIDINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions - US FDA 16 Nov 2022 AZULFIDINE EN-TABS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - EMA PRAC 14 Jun 2019 PRAC signal: Interference with dihydronicotinamide-adenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays
Action for MAH: update of the product information: Yes - EMA PRAC 14 Feb 2019 PRAC signal: Interference with dihydronicotinamide-adenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays
Action for MAH: update of the product information: No
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.