FDA Orange Book
Generic for Permitil
Permitil contains fluphenazine. 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 Permitil is fluphenazine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Permitil products the Orange Book lists.
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Permitil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| concentrate, oral | 5MG/ML | Discontinued | None | 1 | None |
| tablet, extended release, oral | 1MG | Discontinued | None | 0 | None |
| tablet, oral | 0.25MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 15 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 15 | AB |
| tablet, oral | 5MG | Discontinued | None | 15 | AB |
NDA 016008, 012419, 012034, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluphenazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LANNETT CO INC | 089743 | AB (A-rated, therapeutically equivalent) | August 25, 1988 | 10MG, 2.5MG, 5MG |
| PHARMACEUTICAL ASSOCIATES INC | 074725 | None (No TE code listed) | September 16, 1996 | 5MG/ML |
| AMNEAL EU LTD | 213647 | AB (A-rated, therapeutically equivalent) | July 9, 2020 | 10MG, 2.5MG, 5MG |
| DR REDDYS LABORATORIES INC | 214534 | AB (A-rated, therapeutically equivalent) | January 7, 2021 | 10MG, 2.5MG, 5MG |
| NOVITIUM PHARMA LLC | 214674 | AB (A-rated, therapeutically equivalent) | March 1, 2021 | 10MG, 2.5MG, 5MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 214552 | AB (A-rated, therapeutically equivalent) | May 27, 2021 | 10MG, 2.5MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 215141 | AB (A-rated, therapeutically equivalent) | October 20, 2021 | 10MG, 2.5MG, 5MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 215674 | AB (A-rated, therapeutically equivalent) | April 14, 2022 | 10MG, 2.5MG, 5MG |
| UPSHER SMITH LABORATORIES LLC | 213784 | AB (A-rated, therapeutically equivalent) | October 24, 2022 | 10MG, 2.5MG, 5MG |
| AJANTA PHARMA LTD | 217410 | AB (A-rated, therapeutically equivalent) | January 5, 2023 | 10MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 218055 | AB (A-rated, therapeutically equivalent) | August 18, 2023 | 10MG, 2.5MG, 5MG |
| MSN LABORATORIES PRIVATE LTD | 217189 | AB (A-rated, therapeutically equivalent) | September 11, 2023 | 10MG, 2.5MG, 5MG |
| GLENMARK PHARMACEUTICALS LTD | 216350 | AB (A-rated, therapeutically equivalent) | November 6, 2023 | 10MG, 2.5MG, 5MG |
| RISING PHARMA HOLDINGS INC | 218283 | AB (A-rated, therapeutically equivalent) | June 7, 2024 | 10MG, 2.5MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 218173 | AB (A-rated, therapeutically equivalent) | July 23, 2024 | 10MG, 2.5MG, 5MG |
| HETERO LABS LTD UNIT III | 218769 | AB (A-rated, therapeutically equivalent) | November 18, 2025 | 10MG, 2.5MG, 5MG |
Questions
Is there a generic for Permitil?
Yes. The generic name for Permitil is fluphenazine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Permitil products the Orange Book lists.
What is the generic name for Permitil?
The active ingredient in Permitil is fluphenazine, 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.