HydrOXYzine Hydrochloride

Product NDC: 16714-083
11-digit product format: 167140083
Labeler code: 16714
Product ID: 16714-083_1a8febc0-9d51-4026-8ea6-6cba69e841c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrOXYzine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northstar RxLLC
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 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…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995218	Internal RxNorm lookup
995258	Internal RxNorm lookup
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
8e5fce17-936e-46ea-a969-518c952c2091	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
16714-083-10	HydrOXYzine Hydrochloride	100 in 1 BOTTLE	TABLET	100		19
16714-083-11	HydrOXYzine Hydrochloride	500 in 1 BOTTLE	TABLET	500		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-083-04	EA - Each	16714-083	fb08d346-7888-4cb0-b07e-c198fd62b52a	1	2012-07-24
16714-083-05	EA - Each	16714-083	ea0b1c6f-df96-40c4-b96c-7a2353a7e38a	1	2012-07-24
16714-083-10	EA - Each	16714-083	14c212d4-7680-47a1-a64c-cabed21abc2c	1	2013-10-17
16714-083-11	EA - Each	16714-083	eac20784-033b-41f3-a3ca-89f67d92645f	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HydrOXYzine Hydrochloride	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
hydrOXYzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-083	HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]	18	Current NDC, Legacy NDC, 2 package rows	20250206_8e5fce17-936e-46ea-a969-518c952c2091.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 ndc (product): 16714-083
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	8e5fce17-936e-46ea-a969-518c952c2091	19
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	8e5fce17-936e-46ea-a969-518c952c2091	19
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	8e5fce17-936e-46ea-a969-518c952c2091	19
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	19
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	8e5fce17-936e-46ea-a969-518c952c2091	19
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	8e5fce17-936e-46ea-a969-518c952c2091	19
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	8e5fce17-936e-46ea-a969-518c952c2091	19
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	19
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	Marketing end	Sample	Exclude flag	Status
16714-083-10	16714008310	100 TABLET in 1 BOTTLE (16714-083-10)	100 tablet	2009-11-11	0000-00-00	No	No	Current
16714-083-11	16714008311	500 TABLET in 1 BOTTLE (16714-083-11)	500 tablet	2009-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	A-S Medication Solutions	2026-07-21	Human Prescription Drug Label	22
Rx Only	Redpharm Drug	2026-04-18	HUMAN PRESCRIPTION DRUG LABEL	1
Rx Only	Northstar RxLLC \| Piramal Pharma Limited	2025-12-23	Human Prescription Drug Label	19
Rx Only	REMEDYREPACK INC.	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	1