HYDROXYZINE HYDROCHLORIDE

Product NDC: 83745-232
11-digit product format: 837450232
Labeler code: 83745
Product ID: 83745-232_81d956c2-b9db-4f60-9d66-5ca552942e59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: APOZEAL PHARMACEUTICALS INC
Application: ANDA210634
Marketing category: ANDA
Marketing start: 2024-07-16
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 10 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210634-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2019-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210634-001	AA

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 2 · 43 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	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210634-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210634-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210634-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210634-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210634-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210634-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210634-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210634-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210634-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210634-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210634-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210634-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210634-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210634-001	AA	1	`301d65b070ca…`
2019-12-13 00:20 UTC	2019-12	A210634-001	AA	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A210634-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210634-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210634-001	AA	1	`a50c72e98297…`

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 HYDROCHLORIDE	10 mg/5mL

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
995241	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
87d4bbff-0498-4c26-86cb-7ce173afa0b6	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
83745-232-16	HYDROXYZINE HYDROCHLORIDE	473 mL in 1 BOTTLE	SOLUTION	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83745-232-16	ML - Milliliter	83745-232	b608574d-d199-44ed-96a0-58025aeea569	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83745-232	HYDROXYZINE HYDROCHLORIDE SOLUTION [APOZEAL PHARMACEUTICALS INC]	7	Current NDC, 1 package rows	20240730_87d4bbff-0498-4c26-86cb-7ce173afa0b6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	APOZEAL PHARMACEUTICALS INC	87d4bbff-0498-4c26-86cb-7ce173afa0b6	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210634 application number: ANDA210634 ndc (product): 83745-232

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
995241	hydrOXYzine HCl 10 MG in 5 mL Oral Solution	PSN	87d4bbff-0498-4c26-86cb-7ce173afa0b6	8
995241	hydroxyzine hydrochloride 2 MG/ML Oral Solution	SCD	87d4bbff-0498-4c26-86cb-7ce173afa0b6	8
995241	hydroxyzine hydrochloride 10 MG per 5 ML Oral Solution	SY	87d4bbff-0498-4c26-86cb-7ce173afa0b6	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83745-232-16	83745023216	473 mL in 1 BOTTLE (83745-232-16)	473 ml	2024-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Oral Solution, USP 10 mg/5 mL Rx only	APOZEAL PHARMACEUTICALS INC	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	10