FDA Orange Book
Generic for Tofranil-pm
Tofranil-pm contains imipramine. 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 Tofranil-pm is imipramine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tofranil-pm products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG HYDROCHLORIDE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 125MG HYDROCHLORIDE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 150MG HYDROCHLORIDE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 75MG HYDROCHLORIDE | Discontinued | None | 2 | AB |
NDA 017090, held by SPECGX LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic imipramine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 091099 | AB (A-rated, therapeutically equivalent) | April 16, 2010 | EQ 100MG HYDROCHLORIDE, EQ 125MG HYDROCHLORIDE, EQ 150MG HYDROCHLORIDE, EQ 75MG HYDROCHLORIDE |
| LUPIN LTD | 090444 | AB (A-rated, therapeutically equivalent) | April 16, 2010 | EQ 100MG HYDROCHLORIDE, EQ 125MG HYDROCHLORIDE, EQ 150MG HYDROCHLORIDE, EQ 75MG HYDROCHLORIDE |
Questions
Is there a generic for Tofranil-pm?
Yes. The generic name for Tofranil-pm is imipramine. 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 Tofranil-pm?
The active ingredient in Tofranil-pm is imipramine, 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.