Application 088349

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088349-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL			1983-09-15

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088349-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1983-09-15	`3a93d1ddd44b…`

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 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	9ab23881-334c-474d-9d93-25ea225548dc	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride 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 brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	534a6a49-23df-d65e-e063-6294a90a1a12	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	52fb8616-7d4e-9c37-e063-6294a90a1112	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	519e54e0-a613-e7b3-e063-6294a90a4452	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	413a39ce-98d6-40f5-9048-ad464e98de44	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7edd582c-039c-4bdc-bf8a-61eac8a5a9a0	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Incl	63fdf791-1a58-45ba-8ef2-15b80bb24f23	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	ca843456-0c93-41e8-9bbc-9cd92447f092	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	508848a5-017c-dd3e-e063-6294a90a456b	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Redpharm Drug	4fb58637-dc30-c4dd-e063-6394a90a8bbe	2026-04-18	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4cd84205-6a33-db48-e063-6394a90a9182	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Kesin Pharma	4b094d1b-97b2-6ca6-e063-6294a90a2437	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aurobindo Pharma Limited	9de2de56-614f-4294-8794-d30758cf5f70	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	56b49e5c-bb8a-46cd-873c-3c743d1653a4	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	71eea118-395c-4559-aed5-900b635674b8	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	1350964e-663e-4a50-8c4c-cda371a694a0	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	6ad55cd1-a284-4c3d-aa90-653704afdb75	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b3d10f-2599-5b71-e053-2a95a90a54bb	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67296-0381	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	RedPharm Drug Inc.	ANDA	Current