Application 091176

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	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	Approval date
A091176-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07
A091176-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07
A091176-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091176-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2010-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091176-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091176-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A091176-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091176-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091176-003	AB	1	`ea99ee380514…`

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 · 148 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	a9a133e6-efce-4bdb-9335-49c74e57fafe	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Henry Schein, Inc.	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7165a30c-09e4-4ca1-8548-bf71998ba12f	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4789b7ae-314c-43c0-ad33-92ff50085f27	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	24cb9c83-a7e4-4bae-997c-c3a87426f78c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2586	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2587	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2588	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-796	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-816	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5377	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Cardinal Health	ANDA	Current
63629-6518	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Bryant Ranch Prepack	ANDA	Current