Hydroxyzine Hydrochloride

Product NDC: 42806-159
11-digit product format: 428060159
Labeler code: 42806
Product ID: 42806-159_5e33c30d-cf33-4d61-98ca-eab9aab2ddf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA040604
Marketing category: ANDA
Marketing start: 2015-03-31
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
A040604-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28
A040604-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28
A040604-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040604-001	AB
A040604-002	AB
A040604-003	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	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`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	A040604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040604-001	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
82b015dc-999c-46a4-bcaa-a4c81a193b68	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42806-159-01	Hydroxyzine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	12
42806-159-05	Hydroxyzine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	12
42806-159-10	Hydroxyzine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-159-01	EA - Each	42806-159	7e71ce96-945f-47b4-8bc2-4232c48c75e4	1	2015-04-03
42806-159-05	EA - Each	42806-159	a3419756-35bb-462e-b6ba-7c34990bf1b5	1	2015-04-03
42806-159-10	EA - Each	42806-159	8badb465-dffe-41d8-8e3a-d9c25912ca2a	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-159	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	12	Current NDC, Legacy NDC, 3 package rows	20250209_82b015dc-999c-46a4-bcaa-a4c81a193b68.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	Major Pharmaceuticals	7534a3bb-b4cd-415f-8612-53b37dc6d55f	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	157fbedc-b65d-455f-adb5-e7554282e033	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	5ff091be-6e30-4305-a172-769ee45e110b	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Epic Pharma, LLC	82b015dc-999c-46a4-bcaa-a4c81a193b68	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 42806-159
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	99995bdb-a35f-7753-e053-2995a90a683c	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f6f688d0-cb13-40af-a65f-480c37334e37	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	3edfac5c-a08b-4270-a343-9b2dc10a4a6e	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604

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	dd9e5dc5-720c-4de8-abae-6404c31f341f	102
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	dd9e5dc5-720c-4de8-abae-6404c31f341f	102
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	82b015dc-999c-46a4-bcaa-a4c81a193b68	12
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	7b1ba394-d8b3-cb24-e053-2a91aa0ab772	4
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	7b1ba394-d8b3-cb24-e053-2a91aa0ab772	4
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	3
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	413a39ce-98d6-40f5-9048-ad464e98de44	3
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	3
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	3
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	413a39ce-98d6-40f5-9048-ad464e98de44	3
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-159-01	42806015901	100 TABLET, FILM COATED in 1 BOTTLE (42806-159-01)	2015-03-31	0000-00-00	No	No	Current
42806-159-05	42806015905	500 TABLET, FILM COATED in 1 BOTTLE (42806-159-05)	2015-03-31	0000-00-00	No	No	Current
42806-159-10	42806015910	1000 TABLET, FILM COATED in 1 BOTTLE (42806-159-10)	2015-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Preferred Pharmaceuticals Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	102
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Epic Pharma, LLC	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL	12
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	4
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Preferred Pharmaceuticals Inc.	2020-03-02	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	St. Mary's Medical Park Pharmacy \| Epic Pharma, LLC	2019-07-03	HUMAN PRESCRIPTION DRUG LABEL	1