Prescription medicine
Sulfasalazine Brand names: Azulfidine; first approved as Azulfidine En-Tabs
Sulfasalazine (Azulfidine) is a prescription medicine with an FDA approval on record since 1950. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.199 per sulfasalazine 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sulfasalazine FDA label on DailyMed (effective May 29, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 7073 record on Drugs@FDA; every sulfasalazine label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAZULFIDINE Tablets are indicated:
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;
Forms and strengths
- 500 mg
Tablet; delayed-release tablet.
On the market
- Earliest approval on file
- June 20, 1950 Azulfidine En-Tabs, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first November 12, 1973; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.199 per tablet Sulfasalazine 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 77,784 through July 30, 2026
What is sulfasalazine used for?
From the label: indications and usageAZULFIDINE Tablets are indicated:
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
for the prolongation of the remission period between acute attacks of ulcerative colitis.
Conditions named in the indications of sulfasalazine's FDA labels, with every medicine labeled for each:
From other sulfasalazine labelsRheumatoid arthritis: … between acute attacks of ulcerative colitis; c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response …
FDA pharmacologic class: Aminosalicylate.
Source: FDA drug label (Azulfidine), Pfizer Laboratories Div Pfizer Inc, effective May 29, 2026 (SPL set ddbe69f3-bd55-45f3-a64f-f60226c744c4), via openFDA; the full label on DailyMed
Is there a generic for sulfasalazine (Azulfidine)?
The FDA approved the first generic sulfasalazine on November 12, 1973. 10 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sulfasalazine from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1950 earliest approval on file
- 1973 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sulfasalazine (Azulfidine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.199 per Sulfasalazine 500 mg tablet, up 10% from $0.180 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sulfasalazine 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sulfasalazine 500 mg tablet | Generic | $0.199 per tablet | $5.97 | +10% |
| Sulfasalazine DR 500 mg tablet | Generic | $0.286 per tablet | $8.58 | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sulfasalazine been recalled?
The FDA's Enforcement Report lists 2 recalls naming sulfasalazine since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of sulfasalazine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sulfasalazine label say about other medicines?
The sulfasalazine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 28 other medicines name sulfasalazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Drug Interactions Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine. |
Other labels that name sulfasalazine
Source: FDA drug label (Azulfidine), Pfizer Laboratories Div Pfizer Inc, effective May 29, 2026 (SPL set ddbe69f3-bd55-45f3-a64f-f60226c744c4), via openFDA; the full label on DailyMed
What do FAERS reports show for sulfasalazine?
The FDA Adverse Event Reporting System holds 77,784 reports that list sulfasalazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,233 are coded as a death and 21,393 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sulfasalazine?
6 other medicines are given the same way (oral) and in the same FDA class as sulfasalazine or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mesalamine | Crohn's disease and ulcerative colitis | 27 labelers | $0.781 per tablet 1.2 g tablet | A presentation being discontinued |
| Balsalazide | Crohn's disease and ulcerative colitis | 9 labelers | $0.344 per capsule 750 mg capsule | No current entry |
| Olsalazine | Crohn's disease and ulcerative colitis | none listed | $15.70 per capsule 250 mg capsule | No current entry |
| Tofacitinib | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Upadacitinib | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
| Etrasimod arginine | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as sulfasalazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sulfasalazine compare with medicines for the same use?
6 side-by-side pages set sulfasalazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sulfasalazine
- 6 medicines for the same use
- Other aminosalicylates
- the pharmacologic class, with prices and generics
- Sulfasalazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other