HYDROXYZINE HYDROCHLORIDE

Product NDC: 16571-115
11-digit product format: 165710115
Labeler code: 16571
Product ID: 16571-115_20aba551-c0c0-4ea1-8200-ad81956ff294
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA217652
Marketing category: ANDA
Marketing start: 2023-08-22
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 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.

Product history page 1 of 2 · 60 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
2026-02-19 14:30 UTC	2026-02	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2023-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2023-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2023-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2023-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217652-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2023-08-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A217652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217652-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217652-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217652-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217652-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217652-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217652-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217652-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217652-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217652-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217652-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217652-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217652-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217652-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217652-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217652-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217652-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217652-001	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	50 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
6a1a48ac-8ad5-4363-b298-d9825ae2a448	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
16571-115-01	HYDROXYZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
16571-115-10	HYDROXYZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3
16571-115-50	HYDROXYZINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-115	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 3 package rows	20241031_6a1a48ac-8ad5-4363-b298-d9825ae2a448.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 · 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
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 ndc (product): 16571-115
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

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
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	f6ad4729-b291-42c4-8483-99385d8043db	8
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	f6ad4729-b291-42c4-8483-99385d8043db	8
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	6a1a48ac-8ad5-4363-b298-d9825ae2a448	3
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	19b08f92-da63-021f-e063-6394a90a16e2	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	22049012-733e-6b45-e063-6294a90a670f	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	4b8614d9-335c-4141-aaed-445c604ba08c	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	19b08f92-da63-021f-e063-6394a90a16e2	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	22049012-733e-6b45-e063-6294a90a670f	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	4b8614d9-335c-4141-aaed-445c604ba08c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
16571-115-01	16571011501	100 TABLET, FILM COATED in 1 BOTTLE (16571-115-01)	2023-08-22	No	No	Current
16571-115-10	16571011510	1000 TABLET, FILM COATED in 1 BOTTLE (16571-115-10)	2023-08-22	No	No	Current
16571-115-50	16571011550	500 TABLET, FILM COATED in 1 BOTTLE (16571-115-50)	2023-08-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	8
Hydroxyzine Hydrochloride Tablets, USP Rx only	Rising Pharma Holdings, Inc. \| Graviti Pharmaceuticals Private Limited	2025-08-14	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxyzine HCL	Direct_rx	2024-09-13	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Hydrochloride Tablets, USP Rx only	Advanced Rx of Tennessee, LLC	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	1