Application 087871

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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	10MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	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
A087871-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20
A087871-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20
A087871-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A087871-001	AB
A087871-002	AB
A087871-003	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 4 · 129 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	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087871-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087871-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087871-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087871-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087871-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087871-003	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087871-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087871-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087871-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087871-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A087871-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A087871-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087871-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A087871-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A087871-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087871-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087871-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087871-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087871-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087871-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087871-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087871-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087871-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087871-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087871-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087871-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087871-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087871-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A087871-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A087871-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087871-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087871-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087871-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087871-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087871-002	AB	1	`3a93d1ddd44b…`

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 1 of 1 · 11 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	f84e3365-57d2-4904-9275-96600f8d74c7	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aurobindo Pharma Limited	9de2de56-614f-4294-8794-d30758cf5f70	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871 ndc (product): 59651-500 ndc (product): 59651-501 ndc (product): 59651-499
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	56b49e5c-bb8a-46cd-873c-3c743d1653a4	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3526a66b-2182-4b5a-a7d1-563d75f5335f	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9504897e-febc-4293-a2dc-9f79f55ea821	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	eef36dab-c318-44d2-8583-7bae3bfceee7	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	fc148d96-b868-4e45-b7d2-977faf431049	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	a8c83479-f919-49f9-b125-747bd0e3211c	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	7c959515-a5a9-4d5e-90e9-bd58bc947330	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	138ec5c1-bb06-2a82-e063-6394a90ab42b	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-499	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-500	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-501	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current