Hydroxyzine hydrochloride

Product NDC: 80425-0365
11-digit product format: 804250365
Labeler code: 80425
Product ID: 80425-0365_2a994dc6-72f8-0559-e063-6394a90a0ecf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA204279
Marketing category: ANDA
Marketing start: 2023-10-31
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 25 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 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A204279-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204279-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204279-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204279-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204279-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204279-003	AB	1	`caaa826d4ba7…`
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…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	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
09092888-0c18-501d-e063-6294a90aad67	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	SPL version
80425-0365-1	Hydroxyzine hydrochloride	30 in 1 BOTTLE	TABLET	30	2
80425-0365-2	Hydroxyzine hydrochloride	60 in 1 BOTTLE	TABLET	60	2
80425-0365-3	Hydroxyzine hydrochloride	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0365-1	EA - Each	80425-0365	f19c9f42-aac2-4eca-a73d-c5f514bead19	1	2023-12-05
80425-0365-2	EA - Each	80425-0365	b03850c6-4bed-4b1d-985b-533e588c9c1a	1	2023-12-05
80425-0365-3	EA - Each	80425-0365	aeef56c1-9055-4f23-a60c-95e19a30d655	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0365	HYDROXYZINE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250101_09092888-0c18-501d-e063-6294a90aad67.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 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	5a586fc0-e4e0-5621-e063-6294a90a222b	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	583b0ad8-012d-06e5-e063-6294a90a9b12	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
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

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	09092888-0c18-501d-e063-6294a90aad67	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	09092888-0c18-501d-e063-6294a90aad67	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0365-1	80425036501	30 TABLET in 1 BOTTLE (80425-0365-1)	30 tablet	2023-10-31	No	No	Current
80425-0365-2	80425036502	60 TABLET in 1 BOTTLE (80425-0365-2)	60 tablet	2023-10-31	No	No	Current
80425-0365-3	80425036503	90 TABLET in 1 BOTTLE (80425-0365-3)	90 tablet	2023-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine HCL 25mg Tablet Rx only	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2