hydroxyzine pamoate

Product NDC: 71335-1058
11-digit product format: 713351058
Labeler code: 71335
Product ID: 71335-1058_cef1ef27-6965-4aa2-b4f1-9a01e929e937
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA086183
Marketing category: ANDA
Marketing start: 1981-12-14
Marketing end: 2026-05-31
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1058		D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-1	D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-2	D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-3	D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-4	D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-5	D	Discontinued by firm	2026-08-03
excluded package	package	71335-1058	71335-1058-6	D	Discontinued by firm	2026-08-03

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
A086183-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG 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
A086183-001	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	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, 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	A086183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086183-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086183-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086183-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086183-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086183-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086183-001	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1058-1	hydroxyzine pamoate	30 in 1 BOTTLE	CAPSULE	30	5
71335-1058-2	hydroxyzine pamoate	60 in 1 BOTTLE	CAPSULE	60	5
71335-1058-3	hydroxyzine pamoate	90 in 1 BOTTLE	CAPSULE	90	5
71335-1058-4	hydroxyzine pamoate	8 in 1 BOTTLE	CAPSULE	8	5
71335-1058-5	hydroxyzine pamoate	20 in 1 BOTTLE	CAPSULE	20	5
71335-1058-6	hydroxyzine pamoate	42 in 1 BOTTLE	CAPSULE	42	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1058	HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 6 package rows	20230331_acd58331-ba2e-40ad-a5e6-5f19beb6c4cd.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 · 9 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.	55033469-f5c6-5180-e063-6394a90af5eb	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	5505ef8f-0322-b705-e063-6394a90a5c5c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	509e9a9c-23a3-ade4-e063-6294a90a7403	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	0c9101ee-0746-4833-83cf-d0d09e52c0a9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	fcec985f-9ded-6534-e053-6294a90ac76b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1136a291-2f2f-c025-e063-6294a90a76d7	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	2024-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Sandoz Inc	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	2022-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183

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
71335-1058-1	71335105801	30 CAPSULE in 1 BOTTLE (71335-1058-1)	30 capsule	2019-08-16	2026-05-31	No	No	Current
71335-1058-2	71335105802	60 CAPSULE in 1 BOTTLE (71335-1058-2)	60 capsule	2021-12-28	2026-05-31	No	No	Current
71335-1058-3	71335105803	90 CAPSULE in 1 BOTTLE (71335-1058-3)	90 capsule	2019-01-04	2026-05-31	No	No	Current
71335-1058-4	71335105804	8 CAPSULE in 1 BOTTLE (71335-1058-4)	8 capsule	2021-12-28	2026-05-31	No	No	Current
71335-1058-5	71335105805	20 CAPSULE in 1 BOTTLE (71335-1058-5)	20 capsule	2019-10-04	2026-05-31	No	No	Current
71335-1058-6	71335105806	42 CAPSULE in 1 BOTTLE (71335-1058-6)	42 capsule	2019-08-12	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Pamoate Capsules, USP	Bryant Ranch Prepack	2023-03-29	HUMAN PRESCRIPTION DRUG LABEL	5