Application 040156

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 25MG HYDROCHLORIDE	No	No
002	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 50MG HYDROCHLORIDE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040156-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1996-07-15
A040156-002	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1996-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040156-001	AB
A040156-002	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 · 86 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	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040156-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040156-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1996-07-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A040156-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040156-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040156-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040156-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040156-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040156-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040156-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040156-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040156-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040156-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040156-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040156-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040156-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040156-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040156-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040156-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040156-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040156-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040156-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040156-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040156-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040156-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040156-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040156-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040156-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040156-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040156-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040156-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040156-002	AB	1	`74a2ff9319b5…`

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 Pamoate	HYDROXYZINE PAMOATE	Amneal Pharmaceuticals of New York LLC	bc82aaaf-30c7-4afe-a908-d138ea1268ef	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	AvPAK	bff08c15-89b1-00f7-e053-2995a90a2ad8	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DirectRx	d60603e7-15c5-7b01-e053-2995a90ad252	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156 ndc (product): 72189-315
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8a8416f8-18ce-99e6-e053-2995a90a1045	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	4ea3336a-2cc8-4e43-bc55-455fca67976e	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156 ndc (product): 71335-1923
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	42186eab-89d1-4963-bfd8-087b3024af33	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f24c19d4-fd3e-4ed3-aeb7-7bc5e0dd0244	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156 ndc (product): 71335-0998
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	04657694-e8a8-4e52-a179-cfe752819760	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	23561142-45e0-46f5-b17f-d67760b4db27	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NCS HealthCare of KY, LLC dba Vangard Labs	207d3478-ac7f-485c-b8ca-e9fcebbdcd89	2022-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	d6a1df2e-c111-4ee7-9d56-469db19b7c60	2021-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040156 application number: ANDA040156 ndc (product): 71610-217

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 2 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0998	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current
71335-1923	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current
71335-1923	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current
71335-1923	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current
71610-095	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-217	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-217	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-315	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DirectRx	ANDA	Current