FDA Orange Book
Generic for Rowasa
Rowasa contains mesalamine. 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 Rowasa is mesalamine. 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 Rowasa products the Orange Book lists.
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Rowasa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| enema, rectal | 4GM/60ML | Marketed (Rx) | AB | 4 | AB |
| suppository, rectal | 500MG | Discontinued | None | 0 | None |
NDA 019618, 019919, held by MYLAN SPECIALTY LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mesalamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076751 | AB (A-rated, therapeutically equivalent) | September 17, 2004 | 4GM/60ML |
| ENCUBE ETHICALS PRIVATE LTD | 216941 | AB (A-rated, therapeutically equivalent) | May 30, 2023 | 4GM/60ML |
| NOVITIUM PHARMA LLC | 215269 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | 4GM/60ML |
| KLM LABORATORIES PRIVATE LTD | 220016 | AB (A-rated, therapeutically equivalent) | March 31, 2026 | 4GM/60ML |
Rowasa NDC codes
Questions
Is there a generic for Rowasa?
Yes. The generic name for Rowasa is mesalamine. 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 Rowasa products the Orange Book lists.
What is the generic name for Rowasa?
The active ingredient in Rowasa is mesalamine, 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.
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