FDA Orange Book
Generic for Asacol Hd
Asacol Hd 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 Asacol Hd is mesalamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Asacol Hd products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 800MG | Discontinued | None | 3 | AB |
NDA 021830, held by ABBVIE INC. 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 |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 203286 | AB (A-rated, therapeutically equivalent) | July 21, 2017 | 800MG |
| TEVA PHARMACEUTICALS INC | 213191 | AB (A-rated, therapeutically equivalent) | August 22, 2024 | 800MG |
| AMNEAL PHARMACEUTICALS LLC | 215067 | AB (A-rated, therapeutically equivalent) | February 18, 2025 | 800MG |
Questions
Is there a generic for Asacol Hd?
Yes. The generic name for Asacol Hd is mesalamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Asacol Hd?
The active ingredient in Asacol Hd 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.