FDA Orange Book
Generic for Thorazine
Thorazine contains chlorpromazine. 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 Thorazine is chlorpromazine. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 8 of the 16 Thorazine products the Orange Book lists.
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Thorazine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 150MG | Discontinued | None | 0 | None |
| capsule, extended release, oral | 200MG | Discontinued | None | 0 | None |
| capsule, extended release, oral | 300MG | Discontinued | None | 0 | None |
| capsule, extended release, oral | 30MG | Discontinued | None | 0 | None |
| capsule, extended release, oral | 75MG | Discontinued | None | 0 | None |
| concentrate, oral | 100MG/ML | Discontinued | None | 3 | AA |
| concentrate, oral | 30MG/ML | Discontinued | None | 3 | AA |
| injectable, injection | 25MG/ML | Discontinued | None | 9 | AP |
| suppository, rectal | 100MG | Discontinued | None | 0 | None |
| suppository, rectal | 25MG | Discontinued | None | 0 | None |
| syrup, oral | 10MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 12 | AB |
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 200MG | Discontinued | None | 12 | AB |
| tablet, oral | 25MG | Discontinued | None | 12 | AB |
| tablet, oral | 50MG | Discontinued | None | 12 | AB |
NDA 011120, 009149, 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 chlorpromazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS CO GMBH | 209755 | AB (A-rated, therapeutically equivalent) | September 10, 2018 | 100MG, 10MG, 200MG, 25MG, 50MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 213368 | AB (A-rated, therapeutically equivalent) | January 17, 2020 | 100MG, 10MG, 200MG, 25MG, 50MG |
| EUGIA PHARMA SPECIALITIES LTD | 211816 | AP (A-rated, therapeutically equivalent) | July 7, 2020 | 25MG/ML |
| SOMERSET THERAPEUTICS LLC | 213590 | AB (A-rated, therapeutically equivalent) | August 31, 2020 | 100MG, 10MG, 200MG, 25MG, 50MG |
| LANNETT CO INC | 212996 | AB (A-rated, therapeutically equivalent) | January 22, 2021 | 100MG, 10MG, 200MG, 25MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 212144 | AB (A-rated, therapeutically equivalent) | March 23, 2021 | 100MG, 10MG, 200MG, 25MG, 50MG |
| GENUS LIFESCIENCES INC | 214542 | AA (A-rated, therapeutically equivalent) | June 2, 2021 | 100MG/ML, 30MG/ML |
| TEVA PHARMACEUTICALS DEVELOPMENT INC | 215659 | AB (A-rated, therapeutically equivalent) | October 25, 2021 | 100MG, 10MG, 200MG, 25MG, 50MG |
| CHARTWELL RX SCIENCES LLC | 212630 | AB (A-rated, therapeutically equivalent) | November 29, 2021 | 100MG, 10MG, 200MG, 25MG, 50MG |
| MSN LABORATORIES PRIVATE LTD | 214827 | AB (A-rated, therapeutically equivalent) | January 27, 2022 | 100MG, 200MG, 25MG, 50MG |
| LUPIN INC | 213327 | AB (A-rated, therapeutically equivalent) | July 13, 2023 | 100MG, 10MG, 200MG, 25MG, 50MG |
| ALEMBIC PHARMACEUTICALS LTD | 217350 | AB (A-rated, therapeutically equivalent) | July 18, 2023 | 100MG, 10MG, 200MG, 25MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 217275 | AP (A-rated, therapeutically equivalent) | March 13, 2024 | 25MG/ML |
| REGCON HOLDINGS LLC | 218229 | AP (A-rated, therapeutically equivalent) | September 24, 2024 | 25MG/ML |
| GLAND PHARMA LTD | 216911 | AP (A-rated, therapeutically equivalent) | October 4, 2024 | 25MG/ML |
| ASPIRO PHARMA LTD | 218272 | AP (A-rated, therapeutically equivalent) | November 18, 2024 | 25MG/ML |
| RISING PHARMA HOLDINGS INC | 216724 | AP (A-rated, therapeutically equivalent) | December 10, 2024 | 25MG/ML |
| AUROBINDO PHARMA LTD | 216788 | AB (A-rated, therapeutically equivalent) | April 25, 2025 | 100MG, 10MG, 200MG, 25MG, 50MG |
| RUBICON RESEARCH LTD | 216678 | AA (A-rated, therapeutically equivalent) | October 10, 2025 | 100MG/ML, 30MG/ML |
| MSN LABORATORIES PRIVATE LTD | 216092 | AP (A-rated, therapeutically equivalent) | January 26, 2026 | 25MG/ML |
| SCIEGEN PHARMACEUTICALS INC | 080983 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 100MG/ML, 30MG/ML |
| DR REDDYS LABORATORIES LTD | 080365 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 083329 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG/ML |
| UPSHER SMITH LABORATORIES LLC | 084114 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 100MG |
| UPSHER SMITH LABORATORIES LLC | 083386 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| UPSHER SMITH LABORATORIES LLC | 084115 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 200MG |
| UPSHER SMITH LABORATORIES LLC | 084112 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 25MG |
| UPSHER SMITH LABORATORIES LLC | 084113 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG |
Questions
Is there a generic for Thorazine?
Yes. The generic name for Thorazine is chlorpromazine. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 8 of the 16 Thorazine products the Orange Book lists.
What is the generic name for Thorazine?
The active ingredient in Thorazine is chlorpromazine, 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.