Hydroxyzine Hydrochloride

Product NDC: 0404-9877
11-digit product format: 004049877
Labeler code: 0404
Product ID: 0404-9877_0c90956b-50b1-4f90-97b3-e2f831693504
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Henry Schein, Inc.
Application: ANDA087408
Marketing category: ANDA
Marketing start: 2022-01-17
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087408-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
A087408-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

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

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
1794554	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
7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	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
0404-9877-01	Hydroxyzine Hydrochloride	1 in 1 BAG	INJECTION, SOLUTION	1		5
0404-9877-01	Hydroxyzine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9877	HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240529_7279ad5a-0a49-432d-8fa2-17e4c6ecbadc.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Henry Schein, Inc.	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408 ndc (product): 0404-9877
Hydroxyzine	HYDROXYZINE	Henry Schein, Inc.	851e7439-bb0a-4a09-9279-e3c33bff8965	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Regent, Inc.	8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	16a63845-6619-293b-e063-6394a90a0a5c	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408

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
1794554	hydrOXYzine HCl 50 MG in 1 ML Injection	PSN	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	5
1794554	1 ML hydroxyzine hydrochloride 50 MG/ML Injection	SCD	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	5
1794554	hydroxyzine hydrochloride 50 MG per 1 ML Injection	SY	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9877-01	00404987701	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2022-01-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine HCL 50 mg/mL Injection, USP 1mL Single Dose Vial	Henry Schein, Inc.	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	5