Quick answers
- What is Sulfasalazine used for?
- The FDA-approved label (Sulfasalazine, Mylan Pharmaceuticals Inc., August 25, 2026) says: “Sulfasalazine delayed release tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative colitis …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sulfasalazine have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sulfasalazine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sulfasalazine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sulfasalazine?
- 10 companies list prescription products of Sulfasalazine in the FDA NDC Directory, including A-S Medication Solutions, Pfizer Laboratories Div Pfizer Inc and Sunrise Pharmaceutical, Inc..
What Sulfasalazine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sulfasalazine delayed release tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative colitis …
— FDA label: Sulfasalazine, Mylan Pharmaceuticals Inc., effective August 25, 2026. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Azulfidine, Azulfidine En-Tabs |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| sulfasalazine 500 mg tablet | Generic | $0.1985 per tablet |
| sulfasalazine 500 mg tablet, delayed release | Generic | $0.2886 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions2 products
- Pfizer Laboratories Div Pfizer Inc2 products
- Sunrise Pharmaceutical, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Rising Pharma Holdings, Inc.1 product
- Chartwell RX, LLC1 product
- Remedyrepack Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Bryant Ranch Prepack1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA007073 AZULFIDINE, AZULFIDINE EN-TABS | Pfizer | June 20, 1950 | 64, latest October 14, 2026 2026: Labeling · 2022: Labeling · 2021: Labeling |
Generic approvals (5)
- ANDA080197Chartwell · November 12, 1973
- ANDA085828Watson Labs · October 21, 1977
- ANDA040349Nuvo Pharms Inc · January 11, 2002
- ANDA075339Nuvo Pharms Inc · January 11, 2002
- ANDA219046Rising · November 4, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 198232, 313142 |
|---|---|
| SPL set ID of the quoted label | 257cee60-b68f-4c2b-b57d-8e4d73d17e09 |
| FDA labels (SPL) | 11 |
| FDA applications | NDA007073, 5 ANDA |
| Active ingredients (FDA) | SULFASALAZINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sulfasalazine, Mylan Pharmaceuticals Inc., effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →