Hydroxyzine pamoate

Product NDC: 59762-5420
11-digit product format: 597625420
Labeler code: 59762
Product ID: 59762-5420_48d8773d-8fd8-4d5a-9053-f149cae3aa9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Greenstone LLC
Application: NDA011459
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-07-15
Marketing end: 0000-00-00
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	59762-5420		D	Discontinued by firm		2026-08-03
excluded package	package	59762-5420	59762-5420-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	59762-5420		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59762-5420	59762-5420-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
59762-5420-1	EA - Each	59762-5420	025a0880-ab0f-4bfd-931f-234ca64650f1	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-5420	HYDROXYZINE PAMOATE CAPSULE [MYLAN PHARMACEUTICALS INC.]	6	Legacy NDC	20250527_f24bb9df-eed8-4eae-80f3-a6e7853d36f2.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
59762-5420-1	59762542001	100 CAPSULE in 1 BOTTLE (59762-5420-1)	100 capsule	2020-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Pamoate Capsules	Mylan Pharmaceuticals Inc. \| Pfizer Inc	2025-05-22	HUMAN PRESCRIPTION DRUG LABEL	6
Hydroxyzine Pamoate Capsules	REMEDYREPACK INC.	2023-10-02	HUMAN PRESCRIPTION DRUG LABEL	2