HydrOXYzine Hydrochloride

Product NDC: 63739-483
11-digit product format: 637390483
Labeler code: 63739
Product ID: 63739-483_ef689679-6686-19a7-e053-2a95a90a3918
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrOXYzine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA040840
Marketing category: ANDA
Marketing start: 2009-11-11
Marketing end: 0000-00-00
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-483		D	Discontinued by firm		2026-08-07
excluded package	package	63739-483	63739-483-10	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	63739-483		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63739-483	63739-483-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040840-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-483-10	2020-07-22	C162847	48780-1	ab0e2407-2d0f-f274-e053-dbdaa90a6471	Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-483-10	EA - Each	63739-483	7d3a170e-e577-4872-9ac0-7ba5498152f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HydrOXYzine Hydrochloride	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
hydrOXYzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-483	HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]	14	Legacy NDC	20241228_7fff369e-efd8-45c7-bc2b-ca8b623fe716.zip

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	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
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	REMEDYREPACK INC.	58d99cf6-2319-410b-b8be-de9c304541b6	2025-06-17	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-483-10	63739048310	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-483-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	14