Application 088487

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 50MG HYDROCHLORIDE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088487-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1984-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088487-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088487-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088487-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088487-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088487-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088487-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088487-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088487-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088487-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088487-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088487-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088487-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088487-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088487-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088487-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088487-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088487-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088487-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088487-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088487-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088487-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088487-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088487-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088487-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088487-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088487-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088487-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088487-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088487-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088487-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088487-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088487-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088487-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088487-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088487-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088487-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088487-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088487-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088487-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088487-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088487-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	faf7932b-40ee-8822-e053-6394a90a5e40	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	American Health Packaging	e1a7d95c-e6f6-4a89-90b0-002156e90b41	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487 ndc (product): 60687-707
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Teva Pharmaceuticals USA, Inc.	06068fff-2e79-4721-bcc7-b0938aa20e7a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487 ndc (product): 0555-0302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3841	Hydroxyzine Pamoate	Hydroxyzine Pamoate	A-S Medication Solutions	ANDA	Current
50090-3908	Hydroxyzine Pamoate	Hydroxyzine Pamoate	A-S Medication Solutions	ANDA	Current
50090-3908	Hydroxyzine Pamoate	Hydroxyzine Pamoate	A-S Medication Solutions	ANDA	Current
50090-3909	Hydroxyzine Pamoate	Hydroxyzine Pamoate	A-S Medication Solutions	ANDA	Current
51079-078	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Mylan Institutional Inc.	ANDA	Current
51079-078	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Mylan Institutional Inc.	ANDA	Current
53808-0374	Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5092	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Cardinal Health	ANDA	Current
55154-5092	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Cardinal Health	ANDA	Current
60687-707	Hydroxyzine Pamoate	Hydroxyzine Pamoate	American Health Packaging	ANDA	Current
64725-0302	Hydroxyzine Pamoate	Hydroxyzine Pamoate	TYA Pharmaceuticals	ANDA	Current
70518-3311	Hydroxyzine Pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current
70518-3311	Hydroxyzine Pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current
70518-3311	Hydroxyzine Pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current