FDA Orange Book
Generic for Compazine
Compazine contains prochlorperazine. 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 Compazine is prochlorperazine. 21 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 15 Compazine products the Orange Book lists.
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Compazine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| capsule, extended release, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| capsule, extended release, oral | EQ 15MG BASE | Discontinued | None | 0 | None |
| capsule, extended release, oral | EQ 15MG BASE | Discontinued | None | 0 | None |
| capsule, extended release, oral | EQ 30MG BASE | Discontinued | None | 0 | None |
| capsule, extended release, oral | EQ 75MG BASE | Discontinued | None | 0 | None |
| concentrate, oral | EQ 10MG BASE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 5MG BASE/ML | Discontinued | None | 9 | AP |
| suppository, rectal | 2.5MG | Discontinued | None | 0 | None |
| suppository, rectal | 25MG | Discontinued | None | 2 | AB |
| suppository, rectal | 5MG | Discontinued | None | 0 | None |
| syrup, oral | EQ 5MG BASE/5ML | Discontinued | None | 0 | None |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 10 | AB |
| tablet, oral | EQ 25MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 10 | AB |
NDA 011000, 021019, 011276, 010742, 011127, 011188, 010571, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prochlorperazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 089903 | AP (A-rated, therapeutically equivalent) | August 29, 1989 | EQ 5MG BASE/ML |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 040058 | AB (A-rated, therapeutically equivalent) | November 24, 1993 | 25MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 040268 | AB (A-rated, therapeutically equivalent) | February 27, 1998 | EQ 10MG BASE, EQ 5MG BASE |
| PADAGIS US LLC | 040246 | AB (A-rated, therapeutically equivalent) | June 28, 2000 | 25MG |
| SAGENT PHARMACEUTICALS | 040540 | AP (A-rated, therapeutically equivalent) | May 28, 2004 | EQ 5MG BASE/ML |
| AVET LIFESCIENCES LTD | 204147 | AP (A-rated, therapeutically equivalent) | October 15, 2013 | EQ 5MG BASE/ML |
| MYLAN LABORATORIES LTD | 210710 | AP (A-rated, therapeutically equivalent) | October 25, 2018 | EQ 5MG BASE/ML |
| CAPLIN STERILES LTD | 214379 | AP (A-rated, therapeutically equivalent) | April 22, 2021 | EQ 5MG BASE/ML |
| GLAND PHARMA LTD | 214107 | AP (A-rated, therapeutically equivalent) | September 22, 2021 | EQ 5MG BASE/ML |
| VIWIT PHARMACEUTICAL CO LTD | 213626 | AP (A-rated, therapeutically equivalent) | September 28, 2021 | EQ 5MG BASE/ML |
| NOVITIUM PHARMA LLC | 216202 | AB (A-rated, therapeutically equivalent) | June 13, 2022 | EQ 10MG BASE, EQ 5MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 213873 | AP (A-rated, therapeutically equivalent) | July 14, 2022 | EQ 5MG BASE/ML |
| ZYDUS LIFESCIENCES GLOBAL FZE | 216495 | AB (A-rated, therapeutically equivalent) | August 8, 2022 | EQ 10MG BASE, EQ 5MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 216595 | AB (A-rated, therapeutically equivalent) | March 17, 2023 | EQ 10MG BASE, EQ 5MG BASE |
| BIONPHARMA INC | 217478 | AB (A-rated, therapeutically equivalent) | April 4, 2023 | EQ 10MG BASE, EQ 5MG BASE |
| AMNEAL EU LTD | 216598 | AB (A-rated, therapeutically equivalent) | April 17, 2023 | EQ 10MG BASE, EQ 5MG BASE |
| AJANTA PHARMA LTD | 218515 | AB (A-rated, therapeutically equivalent) | May 9, 2024 | EQ 10MG BASE, EQ 5MG BASE |
| SOMERSET THERAPEUTICS LLC | 212257 | AP (A-rated, therapeutically equivalent) | September 13, 2024 | EQ 5MG BASE/ML |
| LEADING PHARMA LLC | 218912 | AB (A-rated, therapeutically equivalent) | September 30, 2024 | EQ 10MG BASE, EQ 5MG BASE |
| DR REDDYS LABORATORIES SA | 217847 | AB (A-rated, therapeutically equivalent) | May 19, 2025 | EQ 10MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 218734 | AB (A-rated, therapeutically equivalent) | September 8, 2025 | EQ 10MG BASE, EQ 5MG BASE |
Questions
Is there a generic for Compazine?
Yes. The generic name for Compazine is prochlorperazine. 21 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 15 Compazine products the Orange Book lists.
What is the generic name for Compazine?
The active ingredient in Compazine is prochlorperazine, 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.