FDA Orange Book
Generic for Haldol
Haldol contains haloperidol. 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 Haldol is haloperidol. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AO, AP.
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Haldol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| concentrate, oral | EQ 2MG BASE/ML | Discontinued | None | 3 | AA |
| injectable, injection | EQ 100MG BASE/ML | Discontinued | None | 9 | AO |
| injectable, injection | EQ 50MG BASE/ML | Discontinued | None | 8 | AO |
| injectable, injection | EQ 5MG BASE/ML | Discontinued | None | 5 | AP |
| tablet, oral | 0.5MG | Discontinued | None | 11 | AB |
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 1MG | Discontinued | None | 12 | AB |
| tablet, oral | 20MG | Discontinued | None | 11 | AB |
| tablet, oral | 2MG | Discontinued | None | 11 | AB |
| tablet, oral | 5MG | Discontinued | None | 12 | AB |
NDA 015922, 018701, 015923, 015921, held by ORTHO MCNEIL PHARMACEUTICAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic haloperidol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 070278 | AB (A-rated, therapeutically equivalent) | June 10, 1986 | 0.5MG, 1MG, 2MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 071209 | AB (A-rated, therapeutically equivalent) | November 17, 1986 | 0.5MG, 1MG, 5MG |
| SCIEGEN PHARMACEUTICALS INC | 071173 | AB (A-rated, therapeutically equivalent) | January 2, 1987 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 071210 | AB (A-rated, therapeutically equivalent) | March 11, 1988 | 10MG |
| CHARTWELL RX SCIENCES LLC | 071211 | AB (A-rated, therapeutically equivalent) | March 11, 1988 | 20MG |
| PHARMACEUTICAL ASSOCIATES INC | 073037 | AA (A-rated, therapeutically equivalent) | February 26, 1993 | EQ 2MG BASE/ML |
| LANNETT CO INC | 073364 | AA (A-rated, therapeutically equivalent) | September 28, 1993 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 074893 | AO (A-rated, therapeutically equivalent) | December 19, 1997 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075305 | AO (A-rated, therapeutically equivalent) | September 28, 1998 | EQ 100MG BASE/ML |
| MYLAN LABORATORIES LTD | 075440 | AO (A-rated, therapeutically equivalent) | February 28, 2000 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| FRESENIUS KABI USA LLC | 075689 | AP (A-rated, therapeutically equivalent) | March 9, 2001 | EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075858 | AP (A-rated, therapeutically equivalent) | June 18, 2001 | EQ 5MG BASE/ML |
| MYLAN LABORATORIES LTD | 078347 | AP (A-rated, therapeutically equivalent) | September 14, 2009 | EQ 5MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 091637 | AP (A-rated, therapeutically equivalent) | September 2, 2011 | EQ 5MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 200742 | AP (A-rated, therapeutically equivalent) | September 2, 2011 | EQ 5MG BASE/ML |
| GLAND PHARMA LTD | 205241 | AO (A-rated, therapeutically equivalent) | May 12, 2017 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 209101 | AO (A-rated, therapeutically equivalent) | July 3, 2018 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| ZYDUS PHARMACEUTICALS USA INC | 211180 | AO (A-rated, therapeutically equivalent) | October 22, 2019 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| APPCO PHARMA LLC | 211061 | AB (A-rated, therapeutically equivalent) | January 8, 2020 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| MEITHEAL PHARMACEUTICALS INC | 214507 | AO (A-rated, therapeutically equivalent) | July 26, 2021 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| MSN LABORATORIES PRIVATE LTD | 216004 | AB (A-rated, therapeutically equivalent) | November 18, 2022 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 077580 | AB (A-rated, therapeutically equivalent) | January 17, 2023 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| MANKIND PHARMA LTD | 216730 | AO (A-rated, therapeutically equivalent) | May 23, 2023 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| RUBICON RESEARCH LTD | 218371 | AA (A-rated, therapeutically equivalent) | January 31, 2024 | EQ 2MG BASE/ML |
| MANKIND PHARMA LTD | 216918 | AB (A-rated, therapeutically equivalent) | April 11, 2024 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| AUROBINDO PHARMA LTD | 218789 | AB (A-rated, therapeutically equivalent) | April 19, 2024 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| CAPLIN STERILES LTD | 219168 | AO (A-rated, therapeutically equivalent) | May 13, 2025 | EQ 100MG BASE/ML, EQ 50MG BASE/ML |
| CREEKWOOD PHARMACEUTICALS LLC | 218162 | AB (A-rated, therapeutically equivalent) | December 18, 2025 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| AIPING PHARMACEUTICAL INC | 071130 | AB (A-rated, therapeutically equivalent) | April 8, 2026 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
| ALEMBIC PHARMACEUTICALS LTD | 214470 | AB (A-rated, therapeutically equivalent) | June 4, 2026 | 10MG, 1MG, 20MG, 2MG, 5MG |
| AJANTA PHARMA LTD | 218210 | AB (A-rated, therapeutically equivalent) | September 14, 2026 | 0.5MG, 10MG, 1MG, 20MG, 2MG, 5MG |
Haldol NDC codes
Questions
Is there a generic for Haldol?
Yes. The generic name for Haldol is haloperidol. 23 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AO, AP.
What is the generic name for Haldol?
The active ingredient in Haldol is haloperidol, 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.