Hydroxyzine Pamoate

Product NDC: 68788-7564
Requested package NDC: 68788-7564-5
11-digit product format: 687887564
Labeler code: 68788
Product ID: 68788-7564_74b421f3-e34b-4797-abc3-c8e67f230546
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA040156
Marketing category: ANDA
Marketing start: 1996-07-15
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7564	68788-7564-5	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040156-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1996-07-15
A040156-002	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1996-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040156-001	AB
A040156-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040156-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040156-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040156-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040156-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040156-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040156-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040156-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040156-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040156-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040156-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040156-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040156-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040156-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040156-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040156-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040156-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040156-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040156-002	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
68788-7564-1	EA - Each	68788-7564	39d33169-6159-4bea-8e37-1ce166e8b042	1	2021-01-08
68788-7564-3	EA - Each	68788-7564	25403e5e-1932-464b-9327-1f2d9e3c14a1	1	2021-01-08
68788-7564-5	EA - Each	68788-7564	2763a6c4-9ebe-4c90-ab46-e897efe7d784	1	2021-01-08
68788-7564-6	EA - Each	68788-7564	542da381-42c0-4cde-8832-d519fe08ebe3	1	2021-01-08
68788-7564-9	EA - Each	68788-7564	d6d74333-4047-4d38-a0e4-e9d2f891d2bf	1	2021-01-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Amneal Pharmaceuticals of New York LLC	bc82aaaf-30c7-4afe-a908-d138ea1268ef	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	AvPAK	bff08c15-89b1-00f7-e053-2995a90a2ad8	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DirectRx	d60603e7-15c5-7b01-e053-2995a90ad252	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8a8416f8-18ce-99e6-e053-2995a90a1045	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	4ea3336a-2cc8-4e43-bc55-455fca67976e	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	42186eab-89d1-4963-bfd8-087b3024af33	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f24c19d4-fd3e-4ed3-aeb7-7bc5e0dd0244	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	04657694-e8a8-4e52-a179-cfe752819760	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	23561142-45e0-46f5-b17f-d67760b4db27	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NCS HealthCare of KY, LLC dba Vangard Labs	207d3478-ac7f-485c-b8ca-e9fcebbdcd89	2022-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	d6a1df2e-c111-4ee7-9d56-469db19b7c60	2021-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156

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
68788-7564-5	68788756405	15 CAPSULE in 1 BOTTLE, PLASTIC (68788-7564-5)	15 capsule	2019-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only	Preferred Pharmaceuticals, Inc.	2021-06-03	HUMAN PRESCRIPTION DRUG LABEL	3