Hydroxyzine Hydrochloride

Product NDC: 0904-6617
11-digit product format: 009046617
Labeler code: 0904
Product ID: 0904-6617_f78ac709-6b0b-438b-8333-bd4a7509cfed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA040604
Marketing category: ANDA
Marketing start: 2015-03-31
Marketing end: 2026-08-31
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7534a3bb-b4cd-415f-8612-53b37dc6d55f	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-03	Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
2022-02-03	Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
2022-01-28	Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
2022-01-28	Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6617-61	Hydroxyzine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		10
0904-6617-61	Hydroxyzine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6617-61	EA - Each	0904-6617	28fdc24e-bb6d-497f-a715-b29caea1058d	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6617	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	7	Current NDC, Legacy NDC, 2 package rows	20250430_7534a3bb-b4cd-415f-8612-53b37dc6d55f.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 ndc (product): 0904-6617
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
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
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	7534a3bb-b4cd-415f-8612-53b37dc6d55f	10
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	7534a3bb-b4cd-415f-8612-53b37dc6d55f	10
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	7534a3bb-b4cd-415f-8612-53b37dc6d55f	10
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	7534a3bb-b4cd-415f-8612-53b37dc6d55f	10
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	157fbedc-b65d-455f-adb5-e7554282e033	7
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	157fbedc-b65d-455f-adb5-e7554282e033	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6617-61	00904661761	100 BLISTER PACK in 1 CARTON (0904-6617-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2015-03-31	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Major Pharmaceuticals	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	11
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only	Cardinal Health 107, LLC	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	8