Application 040562

Type: ANDA
Sponsor: ABLE

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 1.

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
A040562-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL			2004-07-22

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040562-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-22	`cb3db0bc1861…`

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 3 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	4c2c4d8e-c3d1-48c7-8f99-ffa159667465	2026-01-19	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
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	db0dce55-5984-7580-e053-2a95a90a3695	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f30879f6-d6e3-1f87-e053-2995a90abca9	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c134195e-a048-530a-e053-2a95a90ad9f8	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c13455a3-3078-4fe1-e053-2a95a90adf8e	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northstar RxLLC	8e5fce17-936e-46ea-a969-518c952c2091	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	6533bb4f-efbc-4fca-b625-daa1b3978740	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3526a66b-2182-4b5a-a7d1-563d75f5335f	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9504897e-febc-4293-a2dc-9f79f55ea821	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	afa74394-c079-4ad3-b555-270fe0de3d62	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	69a58bc6-c8a4-48ad-ac77-90fac42e0398	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	a8525244-2acb-4e3e-9769-bbc90549a188	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	87b79b7c-0398-47dc-858d-62e44a1b02f4	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	acc99b8f-87f0-eb3a-e053-2995a90aaaed	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	0de7a377-7a8f-4119-b172-1eadb4b7e1be	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	a9a133e6-efce-4bdb-9335-49c74e57fafe	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Henry Schein, Inc.	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE

Application 040562

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#