Hydroxyzine Pamoate

Product NDC: 68084-847
Requested package NDC: 68084-847-01
11-digit product format: 680840847
Labeler code: 68084
Product ID: 68084-847_e0dd2b0e-a05b-8d78-e053-2a95a90a4ca4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA087479
Marketing category: ANDA
Marketing start: 2015-02-10
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: 2023-12-31
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	68084-847	68084-847-01	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 package	package	68084-847	68084-847-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-847	68084-847-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-847-01	EA - Each	68084-847	c172fe22-f18f-4f8f-95a4-2412d29b28be	1	2015-03-03
68084-847-11	EA - Each	68084-847	c58759c8-3159-4ded-b6be-c1da9f271df0	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-847	HYDROXYZINE PAMOATE CAPSULE [AMERICAN HEALTH PACKAGING]	7	Legacy NDC	20240125_1988fa7f-282f-438c-8429-570a0f59c801.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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-847-01	68084084701	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-847-01) > 1 CAPSULE in 1 BLISTER PACK (68084-847-11)	100 blister pack	2015-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Pamoate Capsules, USP Rx Only 8073901/0123	Cardinal Health 107, LLC	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules, USP Rx Only 8073901/0123	American Health Packaging	2024-01-24	HUMAN PRESCRIPTION DRUG LABEL	7