FDA Orange Book
Generic for Surmontil
Surmontil contains trimipramine. 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 Surmontil is trimipramine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Surmontil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 25MG BASE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 2 | AB |
NDA 016792, held by TEVA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trimipramine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ELITE LABORATORIES INC | 077361 | AB (A-rated, therapeutically equivalent) | August 2, 2006 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| BRECKENRIDGE PHARMACEUTICAL INC | 208127 | AB (A-rated, therapeutically equivalent) | April 15, 2016 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
Questions
Is there a generic for Surmontil?
Yes. The generic name for Surmontil is trimipramine. 2 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 Surmontil?
The active ingredient in Surmontil is trimipramine, 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.