Hydroxyzine Hydrochloride

Product NDC: 68071-4499
11-digit product format: 680714499
Labeler code: 68071
Product ID: 68071-4499_1a8d9b76-64fd-adfb-e063-6394a90aafa0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA088617
Marketing category: ANDA
Marketing start: 2013-02-19
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
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	68071-4499-3	`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	68071-4499-3	`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	68071-4499-3	`1332a3947898…`	`d4bfe170f9cd…`

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
A088617-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	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
A088617-001	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	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	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	A088617-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088617-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088617-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088617-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088617-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088617-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088617-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088617-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088617-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088617-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088617-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088617-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088617-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088617-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088617-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088617-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088617-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088617-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088617-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088617-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088617-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088617-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088617-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088617-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088617-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088617-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088617-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088617-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088617-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088617-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088617-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088617-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088617-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088617-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088617-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088617-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088617-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088617-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088617-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088617-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76755771U3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995218	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
714a26a1-371f-ef23-e053-2a95a90a6af6	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-10	HydrOXYzine Hydrochloride Tablets USP
2023-01-30	HydrOXYzine Hydrochloride Tablets USP
2021-02-17	HydrOXYzine Hydrochloride Tablets USP
2021-01-29	HydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4499-3	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4499	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240612_714a26a1-371f-ef23-e053-2a95a90a6af6.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St Mary's Medical Park Pharmacy	9ef6a4b7-362d-61b4-e053-2995a90a0ebb	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7165a30c-09e4-4ca1-8548-bf71998ba12f	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	714a26a1-371f-ef23-e053-2a95a90a6af6	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617 ndc (product): 68071-4499
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3946db7c-dc2d-4329-b9ac-f003d8c6d3e1	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617

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	714a26a1-371f-ef23-e053-2a95a90a6af6	5
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	714a26a1-371f-ef23-e053-2a95a90a6af6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4499-3	68071449903	30 TABLET, FILM COATED in 1 BOTTLE (68071-4499-3)	2018-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Hydrochloride Tablets USP	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5