Hydroxyzine Hydrochloride

Product NDC: 55154-2148
Requested package NDC: 55154-2148-0
11-digit product format: 551542148
Labeler code: 55154
Product ID: 55154-2148_1990038a-5c92-4ccf-8b76-b0da11e5031e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA088618
Marketing category: ANDA
Marketing start: 2025-10-22
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088618-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	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
A088618-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A088618-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088618-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088618-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088618-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088618-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088618-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088618-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088618-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088618-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088618-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088618-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088618-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088618-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088618-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088618-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088618-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088618-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088618-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088618-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088618-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088618-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088618-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088618-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088618-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088618-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088618-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088618-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088618-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088618-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088618-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088618-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088618-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088618-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088618-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088618-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088618-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088618-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088618-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088618-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088618-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE HYDROCHLORIDE	25 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
995258	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
b4d274ce-d616-4835-80ce-76270524ed36	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-2148-0	Hydroxyzine Hydrochloride	10 in 1 BAG	TABLET, FILM COATED	10		1
55154-2148-0	Hydroxyzine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	ca67c061-c743-4ebb-a9d5-ece488060663	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	b4d274ce-d616-4835-80ce-76270524ed36	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618 ndc (package): 55154-2148-0 ndc (product): 55154-2148 ndc11 (package): 55154214800
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1767a886-ec92-39fb-e063-6294a90a1249	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	6ad55cd1-a284-4c3d-aa90-653704afdb75	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	db0dce55-5984-7580-e053-2a95a90a3695	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f90259a-a684-498f-8963-d02eaba2e9db	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b05bd0e-af57-4e74-92f8-a4311330142f	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	d79be126-39cd-4dbb-ad88-0e4c18109dda	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618

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
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	b4d274ce-d616-4835-80ce-76270524ed36	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	b4d274ce-d616-4835-80ce-76270524ed36	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2148-0	55154214800	10 BLISTER PACK in 1 BAG (55154-2148-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-10-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydrOXYzine Hydrochloride Tablets USP 8466401/0226 Rx only	Cardinal Health 107, LLC	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	2