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 6 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	NuCare Pharmaceuticals,Inc.	99995bdb-a35f-7753-e053-2995a90a683c	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	79f38cc2-f72f-3f30-e053-2991aa0ac540	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7b6ebf69-77d5-434f-81a4-3d5587fd431e	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f5be725-8ade-4889-b6b1-7d45f5458546	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9714d429-e7f6-4adf-b3f0-cb21e6edb433	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a8af7dd0-fef8-5c39-e053-2a95a90ae11a	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1bf88820-e5f9-06e7-e063-6294a90a80ad	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	714a26a1-371f-ef23-e053-2a95a90a6af6	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	4b8614d9-335c-4141-aaed-445c604ba08c	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Regent, Inc.	8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	19b08f92-da63-021f-e063-6394a90a16e2	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	16a63845-6619-293b-e063-6394a90a0a5c	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	138ec5c1-bb06-2a82-e063-6394a90ab42b	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	d79be126-39cd-4dbb-ad88-0e4c18109dda	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	c59f24b5-0527-423a-ab14-db1ba1f7763f	2024-04-16	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	2562692e-e9cc-4f81-bdc9-47b7d4233758	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f6f688d0-cb13-40af-a65f-480c37334e37	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	c2bce6a4-9feb-4816-a6d8-151e8ef3314d	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Medsource Pharmaceuticals	13172e1e-2b62-8a67-e063-6394a90a3010	2024-03-07	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.