Hydroxyzine

Product NDC: 52584-610
Requested package NDC: 52584-610-25
11-digit product format: 525840610
Labeler code: 52584
Product ID: 52584-610_d62ea489-83a1-4b70-9532-8aa6109ad010
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: General Injectables & Vaccines, Inc
Application: ANDA087408
Marketing category: ANDA
Marketing start: 2010-03-01
Marketing end: 0000-00-00
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-610	52584-610-25	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Hydroxyzine Hydrochloride	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Hydroxyzine	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2

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
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
30S50YM8OG	HYDROXYZINE	68-88-2	Hydroxyzine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-610-25	52584061025	1 VIAL, MULTI-DOSE in 1 BAG (52584-610-25) > 10 mL in 1 VIAL, MULTI-DOSE	2010-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine HCL 50 mg/mL Injection USP 10 mL Multi Dose Vial	General Injectables & Vaccines, Inc	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	6