Hydroxyzine hydrochloride

Product NDC: 23155-500
11-digit product format: 231550500
Labeler code: 23155
Product ID: 23155-500_2be52341-592e-4a89-acc0-730b0560b132
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA204279
Marketing category: ANDA
Marketing start: 2014-08-20
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204279-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20
A204279-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20
A204279-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204279-001	AB
A204279-002	AB
A204279-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A204279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204279-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204279-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204279-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995218	Internal RxNorm lookup
995258	Internal RxNorm lookup
995281	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
f9ff4b7c-dc81-47af-8371-5c681eb0d876	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#

NDC, Effective, Related label table
NDC	Effective	Related label
23155-500-01	2020-03-26	Rx only
23155-500-05	2020-03-26	Rx only
23155-500-10	2020-03-26	Rx only
23155-500-01	2020-01-31	Rx only
23155-500-05	2020-01-31	Rx only
23155-500-10	2020-01-31	Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
23155-500-01	Hydroxyzine hydrochloride	100 in 1 BOTTLE	TABLET	100	22
23155-500-05	Hydroxyzine hydrochloride	500 in 1 BOTTLE	TABLET	500	22
23155-500-10	Hydroxyzine hydrochloride	1000 in 1 BOTTLE	TABLET	1000	22
23155-500-18	Hydroxyzine hydrochloride	108000 in 1 CONTAINER	TABLET	108000	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-500-01	EA - Each	23155-500	912b07ac-2512-4743-91dc-169d8c48a21b	1	2015-11-12
23155-500-05	EA - Each	23155-500	2c9d5353-9015-4b93-a58d-0c8aa3078c5b	1	2015-11-12
23155-500-10	EA - Each	23155-500	65209e8d-ac27-45c5-8258-67c57a772896	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-500	HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	22	Current NDC, Legacy NDC, 4 package rows	20250519_f9ff4b7c-dc81-47af-8371-5c681eb0d876.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 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7f76580c-96a0-4b56-8986-ff5488bb9869	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	bb4a7d22-2f42-4e9f-bf98-cee43ed14d50	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	c8b441bf-a03e-47b3-8f06-c347f5ca4b70	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	b6189074-e199-4f58-a78d-c04f131c13d9	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	83e8d60d-36fd-4223-b50c-e6615045352a	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5506e802-0efc-a845-e063-6394a90aad0e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Incl	63fdf791-1a58-45ba-8ef2-15b80bb24f23	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	508848a5-017c-dd3e-e063-6294a90a456b	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4cd84205-6a33-db48-e063-6394a90a9182	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	71eea118-395c-4559-aed5-900b635674b8	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	1350964e-663e-4a50-8c4c-cda371a694a0	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	4c2c4d8e-c3d1-48c7-8f99-ffa159667465	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b3d10f-2599-5b71-e053-2a95a90a54bb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c134195e-a048-530a-e053-2a95a90ad9f8	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c13455a3-3078-4fe1-e053-2a95a90adf8e	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	6533bb4f-efbc-4fca-b625-daa1b3978740	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Direct Rx	d956063a-ef48-faca-e053-2995a90a0291	2025-10-06		Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ca015a35-1f94-4f92-9143-3f149982d316	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	2fc9b08a-e675-dbc5-e063-6294a90ad054	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279

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	b52e1759-8be3-4e46-a891-4eaa9270c421	28
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	b52e1759-8be3-4e46-a891-4eaa9270c421	28
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	b52e1759-8be3-4e46-a891-4eaa9270c421	28
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	b52e1759-8be3-4e46-a891-4eaa9270c421	28
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	0c687cbe-ce40-4bc0-b880-5166b5be7a80	24
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	f9ff4b7c-dc81-47af-8371-5c681eb0d876	22
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	71eea118-395c-4559-aed5-900b635674b8	9
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	71eea118-395c-4559-aed5-900b635674b8	9
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	2562692e-e9cc-4f81-bdc9-47b7d4233758	7
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	2562692e-e9cc-4f81-bdc9-47b7d4233758	7
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	c134195e-a048-530a-e053-2a95a90ad9f8	4
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	c134195e-a048-530a-e053-2a95a90ad9f8	4
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	7f76580c-96a0-4b56-8986-ff5488bb9869	4
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	d956063a-ef48-faca-e053-2995a90a0291	3
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	d956063a-ef48-faca-e053-2995a90a0291	3
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	2da6dd2f-90e2-464a-ad2a-292575cb0428	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	2da6dd2f-90e2-464a-ad2a-292575cb0428	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	2fc9b08a-e675-dbc5-e063-6294a90ad054	2
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	b26442f9-f577-4bad-b74c-4afca47ce9bd	1
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	2d752346-31e2-4e92-803f-f1e68c3dba1a	1
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	4f3266f4-00a6-4c0c-bff2-e606913de894	1
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	4f3266f4-00a6-4c0c-bff2-e606913de894	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	4f3266f4-00a6-4c0c-bff2-e606913de894	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	2d752346-31e2-4e92-803f-f1e68c3dba1a	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	b26442f9-f577-4bad-b74c-4afca47ce9bd	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	4f3266f4-00a6-4c0c-bff2-e606913de894	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	4f3266f4-00a6-4c0c-bff2-e606913de894	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	4f3266f4-00a6-4c0c-bff2-e606913de894	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-500-01	23155050001	100 TABLET in 1 BOTTLE (23155-500-01)	100 tablet	2014-08-20	0000-00-00	No	No	Current
23155-500-05	23155050005	500 TABLET in 1 BOTTLE (23155-500-05)	500 tablet	2014-08-20	0000-00-00	No	No	Current
23155-500-10	23155050010	1000 TABLET in 1 BOTTLE (23155-500-10)	1000 tablet	2014-08-20	0000-00-00	No	No	Current
23155-500-18	23155050018	108000 in 1 CONTAINER						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx only	Major Pharmaceuticals	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
Rx only	Preferred Pharmaceuticals Inc	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	NuCare Pharmaceuticals, Inc.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	REMEDYREPACK INC.	2026-02-12	HUMAN PRESCRIPTION DRUG LABEL	9
Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Hydroxyzine HCL	Direct Rx \| DirectRx	2025-10-06	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxyzine Hydrochloride Tablets. Rx only	Golden State Medical Supply, Inc.	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Rx only	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. \| Emcure Pharmaceuticals Limited \| CorePharma, LLC	2025-05-16	HUMAN PRESCRIPTION DRUG LABEL	22
Rx only	A-S Medication Solutions	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	28
Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	24
Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	Bryant Ranch Prepack	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	7
Rx only	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
Rx only	Preferred Pharmaceuticals Inc.	2021-01-28	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	RPK Pharmaceuticals, Inc.	2020-12-21	HUMAN PRESCRIPTION DRUG LABEL	1
Rx only	St. Mary’s Medical Park Pharmacy \| Heritage Pharma Labs, Inc	2019-05-10	HUMAN PRESCRIPTION DRUG LABEL	4
Rx only	Aidarex Pharmaceuticals LLC	2016-11-04	HUMAN PRESCRIPTION DRUG LABEL	1