Hydroxyzine Pamoate

Product NDC: 64725-0323
11-digit product format: 647250323
Labeler code: 64725
Product ID: 64725-0323_11445e6b-4efa-40db-909c-5c6ad3d056cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA088496
Marketing category: ANDA
Marketing start: 1984-07-01
Marketing end: 0000-00-00
Substance: HYDROXYZINE PAMOATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	64725-0323		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-0323	64725-0323-1	I	Inactivated by FDA		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 · 44 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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`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	64725-0323-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-0323-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-0323-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-0323-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-0323-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-0323-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-0323-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-0323-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-0323-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-0323-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-0323-1	`110d247fa046…`	`a55b01930146…`

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

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088496-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088496-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0323-1	2019-11-27	C162847	48780-1	9855e2a2-431d-60a7-e053-dbdaa90a05bd	HYDROXYZINE PAMOATE CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0323-1	Hydroxyzine Pamoate	100 in 1 BOTTLE	CAPSULE	100		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0323	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20140901_1094b1ca-bb30-435c-8b2a-27d9fc79f119.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0323-1	64725032301	100 in 1 BOTTLE	Historical