Hydroxyzine Hydrochloride

Product NDC: 60687-686
Requested package NDC: 60687-686-01
11-digit product format: 606870686
Labeler code: 60687
Product ID: 60687-686_e5c1cd5a-fa60-704b-e053-2995a90a1ab7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA088619
Marketing category: ANDA
Marketing start: 2022-08-20
Marketing end: 0000-00-00
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 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	60687-686	60687-686-01	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A088619-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088619-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`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	A088619-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088619-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088619-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088619-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088619-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088619-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088619-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088619-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088619-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088619-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088619-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088619-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088619-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088619-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088619-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088619-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088619-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088619-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088619-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088619-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088619-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088619-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088619-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088619-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088619-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088619-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088619-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088619-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088619-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088619-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088619-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088619-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088619-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088619-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088619-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088619-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088619-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088619-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088619-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088619-001	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	Strength	SPL version
60687-686-01	Hydroxyzine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		2
60687-686-11	Hydroxyzine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-686-01	EA - Each	60687-686	f78a5d21-1b20-482b-b23d-2f741695049c	1	2022-09-12
60687-686-11	EA - Each	60687-686	fb9bc7b7-3049-4a43-b307-2a92852f86c7	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-686	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2	Legacy NDC, 2 package rows	20240926_47bda4fe-ddb7-4140-900a-970373cc7acc.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f30879f6-d6e3-1f87-e053-2995a90abca9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine HCL	HYDROXYZINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	cd4ea0ea-0d92-b70c-e053-2995a90a62ce	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	642ff329-c551-44f0-b340-49313db868c5	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	Hydroxyzine Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	47bda4fe-ddb7-4140-900a-970373cc7acc	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	47bda4fe-ddb7-4140-900a-970373cc7acc	2
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	47bda4fe-ddb7-4140-900a-970373cc7acc	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	47bda4fe-ddb7-4140-900a-970373cc7acc	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	47bda4fe-ddb7-4140-900a-970373cc7acc	2
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	47bda4fe-ddb7-4140-900a-970373cc7acc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-686-01	60687068601	100 BLISTER PACK in 1 CARTON (60687-686-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-686-11)	100 blister pack	2022-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydrOXYzine Hydrochloride Tablets USP 8466401/0226 Rx only	American Health Packaging	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	3