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 4 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	PD-Rx Pharmaceuticals, Inc.	263d3f22-a105-4abb-8152-be2081eefcde	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc6a12ed-411b-4b0c-8108-58ef7db8da55	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	eef36dab-c318-44d2-8583-7bae3bfceee7	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Direct Rx	d956063a-ef48-faca-e053-2995a90a0291	2025-10-06		Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	fc148d96-b868-4e45-b7d2-977faf431049	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f90259a-a684-498f-8963-d02eaba2e9db	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b05bd0e-af57-4e74-92f8-a4311330142f	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6a1a48ac-8ad5-4363-b298-d9825ae2a448	2025-08-14	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE ORAL	Bionpharma Inc.	39f93633-000e-6c3f-e063-6394a90a5a0b	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ca015a35-1f94-4f92-9143-3f149982d316	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	723b810b-46cc-4c45-ae1f-93ca358e007d	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	2fc9b08a-e675-dbc5-e063-6294a90ad054	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	44c63e67-a9e0-4a4f-b34e-2ca60a981766	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	6577589f-1a80-41d8-847a-70c3f38d8dc0	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	2a343906-0bea-4bd8-bd35-c3f199d9b266	2025-05-30	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.