Application 040580

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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

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
A040580-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27
A040580-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27
A040580-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040580-001	AB
A040580-002	AB
A040580-003	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 3 · 115 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
2026-09-14 22:38:34	2026-08	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-003	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2005-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040580-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-05-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040580-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040580-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040580-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040580-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040580-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040580-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040580-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040580-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040580-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040580-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040580-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040580-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040580-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040580-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040580-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040580-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040580-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040580-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040580-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040580-001	AB	1	`301d65b070ca…`

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.