HYDROXYZINE HYDROCHLORIDE

Product NDC: 60760-990
Requested package NDC: 60760-990-30
11-digit product format: 607600990
Labeler code: 60760
Product ID: 60760-990_30b6f6a5-9c36-af93-e063-6294a90a0228
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA217652
Marketing category: ANDA
Marketing start: 2023-08-22
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 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	RLD / RS	Approval date
A217652-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17
A217652-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17
A217652-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2023-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217652-001	AB
A217652-002	AB
A217652-003	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.

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
2026-08-01 22:54:32	2026-06	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2023-08-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A217652-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217652-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217652-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 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	30b6f7b3-b620-961a-e063-6394a90a487b	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652 ndc (package): 60760-990-30 ndc (product): 60760-990 ndc11 (package): 60760099030
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	5648abce-f20e-717c-e063-6294a90a88ac	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	66be7bde-d2bd-4c65-bde9-0fb9f5be093f	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	534a6a49-23df-d65e-e063-6294a90a1a12	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	52fb8616-7d4e-9c37-e063-6294a90a1112	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	519e54e0-a613-e7b3-e063-6294a90a4452	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7edd582c-039c-4bdc-bf8a-61eac8a5a9a0	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	ca843456-0c93-41e8-9bbc-9cd92447f092	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	f6ad4729-b291-42c4-8483-99385d8043db	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc	4aa896b1-4fd5-513e-e063-6294a90ab950	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	afa74394-c079-4ad3-b555-270fe0de3d62	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	69a58bc6-c8a4-48ad-ac77-90fac42e0398	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	a8525244-2acb-4e3e-9769-bbc90549a188	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	87b79b7c-0398-47dc-858d-62e44a1b02f4	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	a9a133e6-efce-4bdb-9335-49c74e57fafe	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6a1a48ac-8ad5-4363-b298-d9825ae2a448	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	8f41912e-12ce-4174-a0fb-cfb4888d8d58	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	6577589f-1a80-41d8-847a-70c3f38d8dc0	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a35d1fe2-328d-42ff-ba1f-18a7f2f03c88	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652
Hydroxyzine HCL	HYDROXYZINE HCL	Direct_rx	22049012-733e-6b45-e063-6294a90a670f	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217652 application number: ANDA217652

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
30b6f7b3-b620-961a-e063-6394a90a487b	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
60760-990-30	HYDROXYZINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-990-30	EA - Each	60760-990	cce6b376-7acd-4cb8-aaf4-1455f57b0332	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-990	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]	1	Current NDC, 1 package rows	20250331_30b6f7b3-b620-961a-e063-6394a90a487b.zip

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	30b6f7b3-b620-961a-e063-6394a90a487b	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	30b6f7b3-b620-961a-e063-6394a90a487b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60760-990-30	60760099030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-990-30)	2025-03-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets, USP Rx only	St. Mary's Medical Park Pharmacy	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	3