Is there a generic for Hydroxyzine pamoate?

Yes. The FDA Orange Book lists 35 approved generic (ANDA) applications for Hydroxyzine pamoate, 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 pamoate?

VISTARIL (NDA 011459, 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 pamoate are approved?

Hydroxyzine pamoate is approved in the following dosage forms: capsule, suspension.

FDA Orange Book · active-ingredient family

Hydroxyzine pamoate

Hydroxyzine pamoate: 2 brands, 35 generics; first approved Mar 05, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 35 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

VISTARILRLD

PFIZERNDA 011459—3 strengths

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EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

VISTARILRLD

PFIZERNDA 011795—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG HYDROCHLORIDE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (35)

HYDROXYZINE PAMOATE

HERITAGE PHARMAANDA 20150720132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG HYDROCHLORIDE	CAPSULE	ORAL	Rx	AB
EQ 50MG HYDROCHLORIDE	CAPSULE	ORAL	Rx	AB

HYDROXYZINE PAMOATE

IMPAX LABS INCANDA 04015619962 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG HYDROCHLORIDE	CAPSULE	ORAL	Rx	AB
EQ 50MG HYDROCHLORIDE	CAPSULE	ORAL	Rx	AB

HYDROXYZINE PAMOATE

WATSON LABSANDA 0811651991

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

HYDROXYZINE PAMOATE

BEXIMCO PHARMS USAANDA 0811271991

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

HYDROXYZINE PAMOATE

SANDOZANDA 0811281991

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

HYDROXYZINE PAMOATE

SANDOZANDA 0811291991

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

HYDROXYZINE PAMOATE

SUPERPHARMANDA 0890311987

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

HYDROXYZINE PAMOATE

SUPERPHARMANDA 0890321987

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

HYDROXYZINE PAMOATE

SUPERPHARMANDA 0890331987

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

HYDROXYZINE PAMOATE

PAR PHARMANDA 0891451986

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

HYDROXYZINE PAMOATE

PAR PHARMANDA 0891461986

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

"HY-PAM ""25"""

TEVAANDA 0887131985

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

HYDROXYZINE PAMOATE

BARRANDA 0884961984

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

HYDROXYZINE PAMOATE

BARR LABSANDA 0884871984

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

HYDROXYZINE PAMOATE

BARR LABSANDA 0884881984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG HYDROCHLORIDE	CAPSULE	ORAL	Rx	—

HYDROXYZINE PAMOATE

DURAMED PHARMS BARRANDA 0885931984

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

HYDROXYZINE PAMOATE

DURAMED PHARMS BARRANDA 0885941984

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

HYDROXYZINE PAMOATE

DURAMED PHARMS BARRANDA 0885951984

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

HYDROXYZINE PAMOATE

VANGARDANDA 0883921983

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

HYDROXYZINE PAMOATE

VANGARDANDA 0883931983

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 0867281982

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 0877671982

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 0877901982

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 0868401982

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 0867051982

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

HYDROXYZINE PAMOATE

PAR PHARMANDA 0876561982

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

HYDROXYZINE PAMOATE

PAR PHARMANDA 0876571982

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

HYDROXYZINE PAMOATE

PAR PHARMANDA 0876581982

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

HYDROXYZINE PAMOATE

IVAX SUB TEVA PHARMSANDA 0877611982

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

HYDROXYZINE PAMOATE

IVAX SUB TEVA PHARMSANDA 0877601982

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

HYDROXYZINE PAMOATE

SANDOZANDA 087479—

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

HYDROXYZINE PAMOATE

SANDOZANDA 086183—

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 086698—

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 086695—

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

HYDROXYZINE PAMOATE

WATSON LABSANDA 086697—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG HYDROCHLORIDE	CAPSULE	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

Mar 05, 1982

45 yr ago

Most recent approval

Jun 03, 2013

13 yr 4 mo ago

Approvals span 1982–2013 across 37 FDA applications.

Brand (NDA) 25%

Generic (ANDA) 3595%

Hydroxyzine pamoate — 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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