HydrOXYzine Hydrochloride

Product NDC: 67296-2224
Requested package NDC: 67296-2224-1
11-digit product format: 672962224
Labeler code: 67296
Product ID: 67296-2224_4fb58637-dc31-c4dd-e063-6394a90a8bbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrOXYzine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA040840
Marketing category: ANDA
Marketing start: 2009-11-11
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A040840-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31
A040840-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31
A040840-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040840-001	AB
A040840-002	AB
A040840-003	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	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A040840-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040840-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040840-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040840-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040840-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040840-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040840-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040840-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040840-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: HydrOXYzine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76755771U3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995281	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4fb58637-dc30-c4dd-e063-6394a90a8bbe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2224-1	HydrOXYzine Hydrochloride	10 in 1 BOTTLE	TABLET	10		1

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	REMEDYREPACK INC.	58d99cf6-2319-410b-b8be-de9c304541b6	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Redpharm Drug	4fb58637-dc30-c4dd-e063-6394a90a8bbe	2026-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840 ndc (package): 67296-2224-1 ndc (product): 67296-2224 ndc11 (package): 67296222401
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northstar RxLLC	8e5fce17-936e-46ea-a969-518c952c2091	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	acc99b8f-87f0-eb3a-e053-2995a90aaaed	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	723b810b-46cc-4c45-ae1f-93ca358e007d	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ffd33207-3f35-3486-e053-6394a90ac0ae	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	46266803-0905-4ae2-9d17-dbf4c2a08181	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d2e63c6-993c-42b9-91a0-616246789a7b	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8e954579-b0f5-4ce3-bade-0b9b972f6f8b	2023-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	HydrOXYzine Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	4fb58637-dc30-c4dd-e063-6394a90a8bbe	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	4fb58637-dc30-c4dd-e063-6394a90a8bbe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2224-1	67296222401	10 TABLET in 1 BOTTLE (67296-2224-1)	10 tablet	2009-11-11	No	No	Current