Hydroxyzine Hydrochloride

Product NDC: 35356-942
11-digit product format: 353560942
Labeler code: 35356
Product ID: 35356-942_f54809eb-b356-4c02-adde-a458e6b530a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA040787
Marketing category: ANDA
Marketing start: 2012-07-24
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-942		D	Discontinued by firm	2026-10-12
excluded package	package	35356-942	35356-942-30	D	Discontinued by firm	2026-10-12
excluded package	package	35356-942	35356-942-60	D	Discontinued by firm	2026-10-12
excluded package	package	35356-942	35356-942-90	D	Discontinued by firm	2026-10-12

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-942-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-942-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-942-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-942-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-942-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-942-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-942-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-942-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-942-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-942-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-942-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-942-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-942-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-942-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-942-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-942-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-942-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-942-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-942-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-942-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-942-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-942-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-942-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-942-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-942-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-942-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-942-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-942-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-942-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-942-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-942-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-942-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-942-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-942-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-942-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-942-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-942-30	EA - Each	35356-942	06652d90-9ef2-47b1-ba87-bf0882c4c1d3	1	2014-10-03
35356-942-60	EA - Each	35356-942	305299d8-78a9-4be9-8234-b6259be6715f	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, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040787 application number: ANDA040787
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	24cb9c83-a7e4-4bae-997c-c3a87426f78c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040787 application number: ANDA040787

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	HYDROXYZINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE TABLETS, USP	Lake Erie Medical DBA Quality Care Products LLC	2019-10-23	HUMAN PRESCRIPTION DRUG LABEL	7