Is there a generic for Haloperidol?

Yes. The FDA Orange Book lists 65 approved generic (ANDA) applications for Haloperidol, referencing the brand HALDOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Haloperidol?

HALDOL (NDA 015921, ORTHO MCNEIL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Haloperidol are approved?

Haloperidol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Haloperidol

Haloperidol: 2 brands, 65 generics; first approved Feb 02, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 65 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

133

Originator applications

Brand (NDA) products

HALDOLRLD

ORTHO MCNEILNDA 015921—6 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

HALDOL SOLUTAB

ORTHO MCNEIL PHARMNDA 017079—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (65)

HALOPERIDOL

ALEMBICANDA 21447020265 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

AIPING PHARM INCANDA 07113020266 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

CREEKWOOD PHARMSANDA 21816220256 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

AUROBINDO PHARMA LTDANDA 21878920246 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

MANKIND PHARMAANDA 21691820246 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

ZYDUS PHARMS USAANDA 07758020236 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

MSNANDA 21600420226 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

ACTAVIS GROUPANDA 20085420226 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

APPCOANDA 21106120206 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

WATSON LABSANDA 0721131991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0723531991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727271989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727281989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727291989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727301989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727311989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

LEDERLEANDA 0727321989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0715711988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0715721988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0715731988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0713741988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0713751988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0713761988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

CHARTWELL RXANDA 0712101988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

CHARTWELL RXANDA 0712111988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

ROYCE LABSANDA 0717221987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

ROYCE LABSANDA 0717231987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

ROYCE LABSANDA 0717241987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

ROYCE LABSANDA 0717251987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

ROYCE LABSANDA 0721211987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

ROYCE LABSANDA 0721221987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710751987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710761987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PAR PHARMANDA 0713281987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712201987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712211987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

AIPING PHARM INCANDA 0711331987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0709811987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0709821987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0709831987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

WATSON LABSANDA 0709841987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

AIPING PHARM INCANDA 0711281987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

AIPING PHARM INCANDA 0711291987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

QUANTUM PHARMICSANDA 0712551987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

QUANTUM PHARMICSANDA 0712691987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

QUANTUM PHARMICSANDA 0712561987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

QUANTUM PHARMICSANDA 0712571987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

INNOGENIXANDA 07117319876 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712161986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712171986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712181986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

DURAMED PHARMS BARRANDA 0712191986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

CHARTWELL RXANDA 07120919864 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710711986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710721986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710731986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

PUREPAC PHARMANDA 0710741986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

STRIDES PHARMA INTLANDA 07123519865 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

SCSANDA 0707251986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

MYLANANDA 07027819866 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB

HALOPERIDOL

SCSANDA 0707201986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

SCSANDA 0707211986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

SCSANDA 0707221986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

SCSANDA 0707231986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

HALOPERIDOL

SCSANDA 0707241986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Feb 02, 1982

45 yr 1 mo ago

Most recent approval

Jun 04, 2026

1 mo ago

Approvals span 1982–2026 across 67 FDA applications.

Brand (NDA) 23%

Generic (ANDA) 6597%

Haloperidol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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