Is there a generic for Hydroxyzine hydrochloride?

Yes. The FDA Orange Book lists 104 approved generic (ANDA) applications for Hydroxyzine hydrochloride, referencing the brand VISTARIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydroxyzine hydrochloride?

VISTARIL (NDA 011111, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydroxyzine hydrochloride are approved?

Hydroxyzine hydrochloride is approved in the following dosage forms: injectable, syrup, tablet.

FDA Orange Book · active-ingredient family

Hydroxyzine hydrochloride

Hydroxyzine hydrochloride: 3 brands, 104 generics; first approved Jan 22, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 104 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

104

Listed patents

Presentations

146

Originator applications

Brand (NDA) products

VISTARILRLD

PFIZERNDA 011111—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

ATARAXRLD

PFIZERNDA 010392—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

ATARAX

ROERIGNDA 010485—

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10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (104)

HYDROXYZINE HYDROCHLORIDE

SAPTALIS PHARMSANDA 2202712026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

NOVITIUM PHARMAANDA 2196482025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

BIONPHARMAANDA 2192892025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

GRAVITI PHARMSANDA 21765220233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

APOZEAL PHARMSANDA 2106342019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

NUVO PHARMS INCANDA 20712120173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

HERITAGEANDA 20427920143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

LANNETT CO INCANDA 2016742013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

RISINGANDA 09117620103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

AMNEAL PHARMANDA 04080820083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

CHARTWELL RXANDA 04080420083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

SUN PHARM INDS INCANDA 04089920083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HETERO LABS LTD IIIANDA 04080520083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

NORTHSTAR HLTHCAREANDA 04084020083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

SOMERSET THERAPS LLCANDA 04081220083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

KVK TECHANDA 04078620073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

PRINSTON INCANDA 04058020053 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

EPIC PHARMA LLCANDA 04060420043 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

ABLEANDA 0405592004

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

HYDROXYZINE HYDROCHLORIDE

ABLEANDA 0405622004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

ABLEANDA 0405632004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PAI HOLDINGS PHARMANDA 0403912002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

PLIVAANDA 0810541995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HIKMAANDA 0400101994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0811491994

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

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0811501994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0811511994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HALSEYANDA 0893661988

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

HYDROXYZINE HYDROCHLORIDE

HALSEYANDA 0891171988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HALSEYANDA 0893961988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

ALPHARMA US PHARMSANDA 0887851988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

ACTAVIS ELIZABETHANDA 0890711986

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

HYDROXYZINE HYDROCHLORIDE

ACTAVIS ELIZABETHANDA 0890721986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

ACTAVIS ELIZABETHANDA 0890731986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SUN PHARM INDUSTRIESANDA 0893811986

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

HYDROXYZINE HYDROCHLORIDE

SUN PHARM INDUSTRIESANDA 0893821986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SUN PHARM INDUSTRIESANDA 0893831986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

USL PHARMAANDA 0891211986

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

HYDROXYZINE HYDROCHLORIDE

USL PHARMAANDA 0891221986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

USL PHARMAANDA 0891231986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PHARMAFAIRANDA 0888621986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PHARMAFAIRANDA 0891061986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PHARMAFAIRANDA 0888811986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PHARMAFAIRANDA 0891071986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDERLDRS

PLIVAANDA 0886171986

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

HYDROXYZINE HYDROCHLORIDERLDRS

PLIVAANDA 0886181986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDERLD

PLIVAANDA 0886191986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

QUANTUM PHARMICSANDA 0885401985

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

HYDROXYZINE HYDROCHLORIDE

QUANTUM PHARMICSANDA 0885511985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

QUANTUM PHARMICSANDA 0885291985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SUPERPHARMANDA 0887941984

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

HYDROXYZINE HYDROCHLORIDE

SUPERPHARMANDA 0887951984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SUPERPHARMANDA 0887961984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PUREPAC PHARMANDA 0881201984

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

HYDROXYZINE HYDROCHLORIDE

PUREPAC PHARMANDA 0881211984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

PUREPAC PHARMANDA 0881221984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

MUTUAL PHARMANDA 0884091983

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

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0883481983

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

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0883491983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 0883501983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

MUTUAL PHARMANDA 0878571983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

MUTUAL PHARMANDA 0878601983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SUN PHARM INDUSTRIESANDA 0878621983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

FRESENIUS KABI USAANDA 0881841983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

FRESENIUS KABI USAANDA 0881851983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 08787119823 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB

HYDROXYZINE HYDROCHLORIDE

KV PHARMANDA 0877301982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

KV PHARMANDA 0878191982

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

HYDROXYZINE HYDROCHLORIDE

KV PHARMANDA 0878201982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

KV PHARMANDA 0878211982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

KV PHARMANDA 0878221982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

ALTANAANDA 08727319822 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDERLDRS

CHARTWELL RXANDA 0872941982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Rx	AA

HYDROXYZINE HYDROCHLORIDE

STRIDES PHARMA INTLANDA 0876021982

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

HYDROXYZINE HYDROCHLORIDE

STRIDES PHARMA INTLANDA 0876031982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDERLD

STRIDES PHARMA INTLANDA 0876041982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE

BAXTER HLTHCAREANDA 085551—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDERLDRS

AM REGENTANDA 087408—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Rx	—
50MG/ML	INJECTABLE	INJECTION	Rx	—

HYDROXYZINE HYDROCHLORIDE

DR REDDYSANDA 085779—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

FRESENIUS KABI USAANDA 087329—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HOSPIRAANDA 087416—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HOSPIRAANDA 086821—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

HOSPIRAANDA 087546—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SMITH AND NEPHEWANDA 087592—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 086822—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 087591—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 087310—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 087593—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 087595—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SOLOPAKANDA 087596—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 085778—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 087274—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WYETH AYERSTANDA 086258—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

ORGATRAX

ORGANON USA INCANDA 087014—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

RISINGANDA 086880—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/5ML	SYRUP	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

IVAX PHARMSANDA 087216—

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

HYDROXYZINE HYDROCHLORIDE

IVAX PHARMSANDA 087410—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

IVAX PHARMSANDA 087411—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SANDOZANDA 087246—

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

HYDROXYZINE HYDROCHLORIDE

SANDOZANDA 085247—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

SANDOZANDA 087245—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 086827—

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

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 086829—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—

HYDROXYZINE HYDROCHLORIDE

WATSON LABSANDA 086836—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	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

Jan 22, 1982

45 yr 1 mo ago

Most recent approval

Jun 11, 2026

1 mo ago

Approvals span 1982–2026 across 107 FDA applications.

Brand (NDA) 33%

Generic (ANDA) 10497%

Hydroxyzine hydrochloride — 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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