Quick answers
- What is Azulfidine EN-tabs?
- Azulfidine EN-tabs is a brand name of Sulfasalazine, a prescription medicine. The FDA NDC Directory lists 1 Azulfidine EN-tabs product in 1 strength and form.
- Who makes Azulfidine EN-tabs?
- Pfizer holds the FDA application for Azulfidine EN-tabs (NDA007073, approved June 20, 1950).
- Is there a generic or store brand of Azulfidine EN-tabs?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Azulfidine EN-tabs product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Azulfidine EN-tabs been recalled?
- No recall linked to Azulfidine EN-tabs products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Azulfidine EN-tabs is
Each Azulfidine EN-tabs product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Sulfasalazine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sulfasalazine 500 mg tablet, delayed release (oral) | Azulfidine EN-tabs | 2 products, 2 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sulfasalazine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA007073 | Pfizer | June 20, 1950 | 1 |
Companies that list Azulfidine EN-tabs
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Azulfidine EN-tabs products.
- Pfizer Laboratories Div Pfizer Inc1 product
Recalls
No recall linked to Azulfidine EN-tabs products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.