Vistaril

Product NDC: 0069-5410
11-digit product format: 000695410
Labeler code: 0069
Product ID: 0069-5410_1ef274bc-bb89-432e-b085-5d707ca372f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA011459
Marketing category: NDA
Marketing start: 1994-11-28
Marketing end: 0000-00-00
Substance: HYDROXYZINE PAMOATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0069-5410		D	Discontinued by firm		2026-08-03
excluded package	package	0069-5410	0069-5410-66	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011459-002	VISTARIL	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N011459-004	VISTARIL	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N011459-006	VISTARIL	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N011459-002	AB
N011459-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011459-004	VISTARIL	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011459-006	VISTARIL	EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011459-002	VISTARIL	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011459-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011459-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011459-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011459-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011459-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011459-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011459-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011459-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011459-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011459-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011459-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011459-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011459-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011459-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011459-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011459-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011459-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011459-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011459-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011459-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011459-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011459-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011459-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011459-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011459-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011459-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011459-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011459-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011459-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011459-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011459-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011459-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011459-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011459-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011459-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011459-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011459-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011459-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011459-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011459-004	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-5410-66	EA - Each	0069-5410	6b33fc7b-83ed-40dc-86b8-eab71525cc5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
SORBITOL	INACTIVE INGREDIENT	506T60A25R	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE VISTARIL (HYDROXYZINE PAMOATE) SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-5410	VISTARIL (HYDROXYZINE PAMOATE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	19	Legacy NDC	20240918_c271f97f-040e-492b-9194-2c8b74675a95.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M20215MUFR	HYDROXYZINE PAMOATE	10246-75-0	HYDROXYZINE PAMOATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-5410-66	00069541066	100 CAPSULE in 1 BOTTLE (0069-5410-66)	100 capsule	1994-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VISTARIL ® (hydroxyzine pamoate) Capsules and Oral Suspension	Pfizer Laboratories Div Pfizer Inc	2024-09-16	HUMAN PRESCRIPTION DRUG LABEL	19