Application 040786

Type: ANDA
Sponsor: KVK TECH

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 1.

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
A040786-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20
A040786-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20
A040786-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040786-001	AB
A040786-002	AB
A040786-003	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 · 123 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	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2007-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2007-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040786-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-03-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040786-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040786-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040786-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040786-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040786-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040786-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040786-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040786-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040786-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040786-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040786-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040786-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040786-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040786-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040786-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040786-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040786-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040786-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040786-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040786-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4789b7ae-314c-43c0-ad33-92ff50085f27	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040786 application number: ANDA040786 ndc (product): 43063-943
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040786 application number: ANDA040786 ndc (product): 43063-960
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc6a12ed-411b-4b0c-8108-58ef7db8da55	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040786 application number: ANDA040786 ndc (product): 43063-627
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f5be725-8ade-4889-b6b1-7d45f5458546	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040786 application number: ANDA040786
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	KVK-Tech, Inc.	adc4cb73-77c6-48ff-aaf2-b3568d53de1f	2023-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040786 application number: ANDA040786 ndc (product): 10702-010 ndc (product): 10702-012 ndc (product): 10702-011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1525	Hydroxyzine	Hydroxyzine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1526	Hydroxyzine	Hydroxyzine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1527	Hydroxyzine	Hydroxyzine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10702-010	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-010	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-011	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-012	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	KVK-Tech, Inc.	ANDA	Current
43063-627	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-627	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-627	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-943	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-943	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-943	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-943	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-943	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-960	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0122	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	A-S Medication Solutions	ANDA	Current
63629-7087	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-5086	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5086	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-253	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-253	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-253	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-253	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-254	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-254	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-255	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68084-255	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Health Packaging	ANDA	Current
68788-9737	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1068	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Bryant Ranch Prepack	ANDA	Current