FDA Orange Book
Generic for Azulfidine
Azulfidine contains sulfasalazine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Azulfidine is sulfasalazine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Azulfidine products the Orange Book lists.
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Azulfidine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 250MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Marketed (Rx) | AB | 4 | AB |
NDA 018605, 007073, held by PHARMACIA AND UPJOHN CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sulfasalazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NUVO PHAMACEUTICALS INC | 040349 | AB (A-rated, therapeutically equivalent) | January 11, 2002 | 500MG |
| RISING PHARMA HOLDINGS INC | 219046 | AB (A-rated, therapeutically equivalent) | November 4, 2025 | 500MG |
| CHARTWELL PHARMA SCIENCE LLC | 080197 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 500MG |
| WATSON LABORATORIES INC | 085828 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 500MG |
Azulfidine NDC codes
Questions
Is there a generic for Azulfidine?
Yes. The generic name for Azulfidine is sulfasalazine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Azulfidine products the Orange Book lists.
What is the generic name for Azulfidine?
The active ingredient in Azulfidine is sulfasalazine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.