FDA Orange Book
Generic for Prolixin
Prolixin 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 Prolixin is fluphenazine. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Prolixin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| elixir, oral | 2.5MG/5ML | Discontinued | None | 1 | None |
| injectable, injection | 2.5MG/ML | Discontinued | None | 1 | None |
| tablet, oral | 10MG | Discontinued | None | 15 | AB |
| tablet, oral | 1MG | Discontinued | None | 15 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 15 | AB |
| tablet, oral | 5MG | Discontinued | None | 15 | AB |
NDA 012145, 011751, held by APOTHECON INC DIV BRISTOL MYERS SQUIBB. 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 |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 089556 | None (No TE code listed) | April 16, 1987 | 2.5MG/ML |
| LANNETT CO INC | 089743 | AB (A-rated, therapeutically equivalent) | August 25, 1988 | 10MG, 1MG, 2.5MG, 5MG |
| PHARMACEUTICAL ASSOCIATES INC | 040146 | None (No TE code listed) | August 21, 1996 | 2.5MG/5ML |
| AMNEAL EU LTD | 213647 | AB (A-rated, therapeutically equivalent) | July 9, 2020 | 10MG, 1MG, 2.5MG, 5MG |
| DR REDDYS LABORATORIES INC | 214534 | AB (A-rated, therapeutically equivalent) | January 7, 2021 | 10MG, 1MG, 2.5MG, 5MG |
| NOVITIUM PHARMA LLC | 214674 | AB (A-rated, therapeutically equivalent) | March 1, 2021 | 10MG, 1MG, 2.5MG, 5MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 214552 | AB (A-rated, therapeutically equivalent) | May 27, 2021 | 10MG, 1MG, 2.5MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 215141 | AB (A-rated, therapeutically equivalent) | October 20, 2021 | 10MG, 1MG, 2.5MG, 5MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 215674 | AB (A-rated, therapeutically equivalent) | April 14, 2022 | 10MG, 1MG, 2.5MG, 5MG |
| UPSHER SMITH LABORATORIES LLC | 213784 | AB (A-rated, therapeutically equivalent) | October 24, 2022 | 10MG, 1MG, 2.5MG, 5MG |
| AJANTA PHARMA LTD | 217410 | AB (A-rated, therapeutically equivalent) | January 5, 2023 | 10MG, 1MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 218055 | AB (A-rated, therapeutically equivalent) | August 18, 2023 | 10MG, 1MG, 2.5MG, 5MG |
| MSN LABORATORIES PRIVATE LTD | 217189 | AB (A-rated, therapeutically equivalent) | September 11, 2023 | 10MG, 1MG, 2.5MG, 5MG |
| GLENMARK PHARMACEUTICALS LTD | 216350 | AB (A-rated, therapeutically equivalent) | November 6, 2023 | 10MG, 1MG, 2.5MG, 5MG |
| RISING PHARMA HOLDINGS INC | 218283 | AB (A-rated, therapeutically equivalent) | June 7, 2024 | 10MG, 1MG, 2.5MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 218173 | AB (A-rated, therapeutically equivalent) | July 23, 2024 | 10MG, 1MG, 2.5MG, 5MG |
| HETERO LABS LTD UNIT III | 218769 | AB (A-rated, therapeutically equivalent) | November 18, 2025 | 10MG, 1MG, 2.5MG, 5MG |
Questions
Is there a generic for Prolixin?
Yes. The generic name for Prolixin is fluphenazine. 17 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 Prolixin?
The active ingredient in Prolixin 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.