FDA Orange Book
Generic for Anafranil
Anafranil contains clomipramine. 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 Anafranil is clomipramine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Anafranil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Marketed (Rx) | AB | 12 | AB |
| capsule, oral | 50MG | Marketed (Rx) | AB | 12 | AB |
| capsule, oral | 75MG | Marketed (Rx) | AB | 12 | AB |
NDA 019906, 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 clomipramine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 074364 | AB (A-rated, therapeutically equivalent) | March 29, 1996 | 25MG, 50MG, 75MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 074694 | AB (A-rated, therapeutically equivalent) | December 31, 1996 | 25MG, 50MG, 75MG |
| SANDOZ INC | 074953 | AB (A-rated, therapeutically equivalent) | June 25, 1997 | 25MG, 50MG, 75MG |
| ZYDUS PHARMACEUTICALS USA INC | 208961 | AB (A-rated, therapeutically equivalent) | December 27, 2017 | 25MG, 50MG, 75MG |
| LUPIN LTD | 209294 | AB (A-rated, therapeutically equivalent) | November 21, 2018 | 25MG, 50MG, 75MG |
| MANKIND PHARMA LTD | 211767 | AB (A-rated, therapeutically equivalent) | April 8, 2019 | 25MG, 50MG, 75MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 212218 | AB (A-rated, therapeutically equivalent) | October 21, 2019 | 25MG, 50MG, 75MG |
| LEADING PHARMA LLC | 211364 | AB (A-rated, therapeutically equivalent) | February 7, 2020 | 25MG, 50MG, 75MG |
| MICRO LABS LTD | 213219 | AB (A-rated, therapeutically equivalent) | June 22, 2020 | 25MG, 50MG, 75MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 212285 | AB (A-rated, therapeutically equivalent) | August 7, 2020 | 25MG, 50MG, 75MG |
| ALEMBIC PHARMACEUTICALS LTD | 211822 | AB (A-rated, therapeutically equivalent) | August 4, 2021 | 25MG, 50MG, 75MG |
| AUROBINDO PHARMA LTD | 216440 | AB (A-rated, therapeutically equivalent) | March 20, 2023 | 25MG, 50MG, 75MG |
Anafranil NDC codes
Questions
Is there a generic for Anafranil?
Yes. The generic name for Anafranil is clomipramine. 12 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 Anafranil?
The active ingredient in Anafranil is clomipramine, 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.