FDA Orange Book
Generic for Mexitil
Mexitil contains mexiletine. 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 Mexitil is mexiletine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mexitil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 10 | AB |
| capsule, oral | 200MG | Discontinued | None | 10 | AB |
| capsule, oral | 250MG | Discontinued | None | 10 | AB |
NDA 018873, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mexiletine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 074377 | AB (A-rated, therapeutically equivalent) | May 16, 1995 | 150MG, 200MG, 250MG |
| ANI PHARMACEUTICALS INC | 074450 | AB (A-rated, therapeutically equivalent) | May 16, 1996 | 150MG, 200MG, 250MG |
| CROSSMEDIKA SA | 213500 | AB (A-rated, therapeutically equivalent) | July 22, 2020 | 150MG, 200MG, 250MG |
| INGENUS PHARMACEUTICALS LLC | 214352 | AB (A-rated, therapeutically equivalent) | January 25, 2021 | 150MG, 200MG, 250MG |
| PHARMAZONE | 214089 | AB (A-rated, therapeutically equivalent) | October 1, 2021 | 150MG, 200MG, 250MG |
| RISING PHARMA HOLDINGS INC | 215315 | AB (A-rated, therapeutically equivalent) | August 26, 2022 | 150MG, 200MG, 250MG |
| ANNORA PHARMA PRIVATE LTD | 216463 | AB (A-rated, therapeutically equivalent) | November 9, 2022 | 150MG, 200MG, 250MG |
| QUAGEN PHARMACEUTICALS LLC | 215876 | AB (A-rated, therapeutically equivalent) | February 27, 2023 | 150MG, 200MG, 250MG |
| MACLEODS PHARMACEUTICALS LTD | 219987 | AB (A-rated, therapeutically equivalent) | March 23, 2026 | 150MG, 200MG, 250MG |
| ZYDUS PHARMACEUTICALS USA INC | 214598 | AB (A-rated, therapeutically equivalent) | September 23, 2026 | 150MG, 200MG, 250MG |
Questions
Is there a generic for Mexitil?
Yes. The generic name for Mexitil is mexiletine. 10 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 Mexitil?
The active ingredient in Mexitil is mexiletine, 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.