Application 040604

Type: ANDA
Sponsor: EPIC 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 42.

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
A040604-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28
A040604-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28
A040604-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040604-001	AB
A040604-002	AB
A040604-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2004-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2004-12-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040604-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040604-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040604-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040604-001	AB	1	`1e350fbaab3a…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7534a3bb-b4cd-415f-8612-53b37dc6d55f	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 0904-6617 ndc (product): 0904-6618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	157fbedc-b65d-455f-adb5-e7554282e033	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 55154-7994
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	5ff091be-6e30-4305-a172-769ee45e110b	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Epic Pharma, LLC	82b015dc-999c-46a4-bcaa-a4c81a193b68	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 42806-161
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	99995bdb-a35f-7753-e053-2995a90a683c	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 68071-5133
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f6f688d0-cb13-40af-a65f-480c37334e37	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 71335-2185
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	3edfac5c-a08b-4270-a343-9b2dc10a4a6e	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040604 application number: ANDA040604 ndc (product): 71205-332

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6617	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6617	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6617	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6618	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6618	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6618	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Major Pharmaceuticals	ANDA	Current
42806-161	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-161	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Epic Pharma, LLC	ANDA	Current
55154-7994	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Cardinal Health	ANDA	Current
68071-5133	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5133	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2240	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3574	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-285	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-285	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-332	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-332	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-332	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-2185	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53937	ORIG	2018-05-01