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Active ingredient

Sulfasalazine

14 finished FDA listings contain Sulfasalazine as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
SULFASALAZINE
Dosage forms
Tablet, Tablet, Delayed Release
Routes
Oral
Manufacturers / labelers
10
Strengths listed
500 mg/1
Brand names in FDA listings
Azulfidine, Azulfidine En-Tabs

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 9524

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 007073PFIZER1950-06-208
ANDA 080197CHARTWELL1973-11-121
ANDA 085828WATSON LABS1977-10-212
ANDA 040349NUVO PHARMS INC2002-01-111
ANDA 075339NUVO PHARMS INC2002-01-111
ANDA 219046RISING2025-11-041

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.