hydroxyzine pamoate

Product NDC: 0615-7860
11-digit product format: 006157860
Labeler code: 0615
Product ID: 0615-7860_ff991d00-b2c8-4957-afdb-e4ede4d35f1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA087479
Marketing category: ANDA
Marketing start: 2014-06-27
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	0615-7860		D	Discontinued by firm		2026-08-03
excluded package	package	0615-7860	0615-7860-39	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7860-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7860-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7860-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7860-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7860-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7860-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7860-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7860-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7860-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7860-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7860-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7860-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7860-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7860-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7860-39	E	Excluded after deficient or non-compliant submission was not corrected	`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
A087479-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087479-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`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	A087479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087479-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087479-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087479-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7860-39	2021-06-16	C162847	48780-1	9d75b9d0-39d6-f424-e053-dadaa90a57ce	HydrOXYzine Pamoate Capsules USP, 25 mg and 50 mg R x only
0615-7860-39	2020-01-31	C162847	48780-1	9d75b9d0-39d6-f424-e053-dadaa90a57ce	HydrOXYzine Pamoate Capsules USP, 25 mg and 50 mg R x only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	561d8abe-97e8-5dc7-e063-6294a90a3923	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	6432d1aa-1e73-469e-835b-43d518963f71	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	2e59dc14-7e17-4663-bc1f-7ee8e104dbfa	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	55012f2c-fa10-2a31-e063-6294a90ae718	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	545f0e87-2688-5381-e063-6394a90a72d4	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	98a1c161-5728-4626-a6b0-5414935e4eef	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8a7084e0-530c-607b-e053-2a95a90a229c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	f99da162-f224-1c19-e053-6294a90acffb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	53153595-41b9-4b2d-8b7d-0ffd29fdd1d8	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	836ec7f1-e739-4b85-bb52-08d5c5ed4c11	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	2a869704-2ad0-4ef6-89e6-0f84c39542b6	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	54af47cd-65c2-4bc9-95cd-7883e56ed035	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	aee7c4a8-10cb-2107-e053-2995a90a90e7	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	34f7e401-9b2c-7d63-e063-6394a90a1f00	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f74e4b3e-992c-402d-92b8-258fccb42b64	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	02616eee-a1a4-4afc-b84e-69fd28755138	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceutcals, Inc.	2879c79f-bf2f-0bc9-e063-6394a90a98ae	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	fac2df9d-d395-4b07-b299-2ed946441b22	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Pharmasource Meds, LLC	f563aa1a-1e21-49d4-e053-2a95a90a3264	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	c29f005e-ae75-415d-9fd6-591f074dcda5	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479

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, 25 mg and 50 mg R x only	NCS HealthCare of KY, Inc dba Vangard Labs	2014-11-12	HUMAN PRESCRIPTION DRUG LABEL	1