Application 010392

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATARAX	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	ATARAX	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ATARAX	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	ATARAX	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N010392-001	ATARAX	HYDROXYZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N010392-004	ATARAX	HYDROXYZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N010392-005	ATARAX	HYDROXYZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N010392-006	ATARAX	HYDROXYZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010392-001	ATARAX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010392-004	ATARAX	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010392-005	ATARAX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010392-006	ATARAX	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`

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 2 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f84e3365-57d2-4904-9275-96600f8d74c7	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	9ab23881-334c-474d-9d93-25ea225548dc	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7534a3bb-b4cd-415f-8612-53b37dc6d55f	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1767a886-ec92-39fb-e063-6294a90a1249	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	534a6a49-23df-d65e-e063-6294a90a1a12	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	52fb8616-7d4e-9c37-e063-6294a90a1112	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	519e54e0-a613-e7b3-e063-6294a90a4452	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	413a39ce-98d6-40f5-9048-ad464e98de44	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7edd582c-039c-4bdc-bf8a-61eac8a5a9a0	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Incl	63fdf791-1a58-45ba-8ef2-15b80bb24f23	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	ca843456-0c93-41e8-9bbc-9cd92447f092	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	508848a5-017c-dd3e-e063-6294a90a456b	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Redpharm Drug	4fb58637-dc30-c4dd-e063-6394a90a8bbe	2026-04-18	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4cd84205-6a33-db48-e063-6394a90a9182	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	f6ad4729-b291-42c4-8483-99385d8043db	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Kesin Pharma	4b094d1b-97b2-6ca6-e063-6294a90a2437	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aurobindo Pharma Limited	9de2de56-614f-4294-8794-d30758cf5f70	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	56b49e5c-bb8a-46cd-873c-3c743d1653a4	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	71eea118-395c-4559-aed5-900b635674b8	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
218	SUPPL	2001-03-21