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 5 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	Bryant Ranch Prepack	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	a8c83479-f919-49f9-b125-747bd0e3211c	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	7c959515-a5a9-4d5e-90e9-bd58bc947330	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f9ff4b7c-dc81-47af-8371-5c681eb0d876	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	b52e1759-8be3-4e46-a891-4eaa9270c421	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	a2fbc502-6ca3-4304-9069-b7249c9d9489	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	5ff091be-6e30-4305-a172-769ee45e110b	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	dd9e5dc5-720c-4de8-abae-6404c31f341f	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	d03fdfd0-5dbd-40fe-a6e3-082a47751c2c	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0c687cbe-ce40-4bc0-b880-5166b5be7a80	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	31a907e6-7fae-0682-e063-6294a90a24a5	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	43889411-a303-41a1-b03b-1ee46f452c54	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ffd33207-3f35-3486-e053-6394a90ac0ae	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Epic Pharma, LLC	82b015dc-999c-46a4-bcaa-a4c81a193b68	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	09092888-0c18-501d-e063-6294a90aad67	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Asclemed USA, Inc.	4f3266f4-00a6-4c0c-bff2-e606913de894	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Sunrise Pharmaceutical, Inc.	94561525-a565-4193-b64d-e1459ab05678	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	934afb42-fee8-415b-8090-2265bb299afe	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE	Amneal Pharmaceuticals LLC	89901966-724b-4773-98b8-ea663ceabd53	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	53b2d731-f38a-47c0-9e5c-abd3b45e2fe1	2024-10-22	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.