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 7 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	A-S Medication Solutions	3946db7c-dc2d-4329-b9ac-f003d8c6d3e1	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	e83de74d-b2e0-45c5-b072-170a96216d3a	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	80e60583-76d3-4e65-8581-4cdaff7cd1c1	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	4590101d-7fb2-478b-acc5-bc9bdbb38ca9	2023-10-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d618157e-f43f-4b31-ba5b-8a13a94885bc	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	2e346b0c-9407-4346-82c2-d9755cbcd8b0	2023-09-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	49ee4ecf-b2c0-4301-89da-111e4d853168	2023-09-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	46266803-0905-4ae2-9d17-dbf4c2a08181	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d5d3ebf-e57e-4ed1-be97-d4b299fb738d	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d2e63c6-993c-42b9-91a0-616246789a7b	2023-09-07	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	92d8cc57-7e3a-4217-9160-e1b56db5570e	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Lannett Company, Inc.	a4fb61ae-aad6-4bd6-83fc-8b227f175df9	2023-01-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8e954579-b0f5-4ce3-bade-0b9b972f6f8b	2023-01-23	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	KVK-Tech, Inc.	adc4cb73-77c6-48ff-aaf2-b3568d53de1f	2023-01-04	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f7e527fe-2f67-45ad-a3ec-146ead819514	2022-11-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	3edfac5c-a08b-4270-a343-9b2dc10a4a6e	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	642ff329-c551-44f0-b340-49313db868c5	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	daefb617-209a-428b-9567-adc5880fa65c	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	bcddc5ce-6cfb-4a09-8e6c-c956b65e3188	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	73993c7e-acd7-4835-be03-f8274a15955b	2022-06-01	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.