Hydroxyzine Pamoate

Product NDC: 55154-5564
11-digit product format: 551545564
Labeler code: 55154
Product ID: 55154-5564_c3ea9714-114b-4dbe-b829-dcaa9da428ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health
Application: ANDA088496
Marketing category: ANDA
Marketing start: 2012-09-25
Marketing end: 2020-09-30
Substance: HYDROXYZINE PAMOATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55154-5564		D	Discontinued by firm		2026-08-17
excluded package	package	55154-5564	55154-5564-0	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-5564-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-5564-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-5564-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-5564-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-5564-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-5564-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-5564-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-5564-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-5564-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-5564-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-5564-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-5564-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088496-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1984-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088496-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088496-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088496-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088496-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088496-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088496-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088496-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088496-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088496-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088496-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088496-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088496-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088496-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088496-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088496-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088496-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088496-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088496-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088496-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088496-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088496-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088496-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088496-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088496-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088496-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088496-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088496-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088496-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088496-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088496-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088496-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088496-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088496-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088496-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088496-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088496-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088496-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088496-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088496-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088496-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088496-001	AB	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]	5

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088496 application number: ANDA088496
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	American Health Packaging	e1a7d95c-e6f6-4a89-90b0-002156e90b41	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088496 application number: ANDA088496
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	ea1c7326-52ea-4934-844c-892d868042cf	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088496 application number: ANDA088496
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Teva Pharmaceuticals USA, Inc.	06068fff-2e79-4721-bcc7-b0938aa20e7a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088496 application number: ANDA088496
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	b098e287-e489-4cdc-9171-7daf50380c1c	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088496 application number: ANDA088496

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Pamoate Capsules USP	Cardinal Health \| UDL Laboratories, Inc.	2020-07-10	HUMAN PRESCRIPTION DRUG LABEL	10