HYDROXYZINE HCL

Product NDC: 61919-856
11-digit product format: 619190856
Labeler code: 61919
Product ID: 61919-856_eac3b1b0-6bfc-f549-e053-2a95a90ac25d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA040602
Marketing category: ANDA
Marketing start: 2019-04-30
Marketing end: 0000-00-00
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-856		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-856	61919-856-30	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-856	61919-856-60	I	Inactivated by FDA	2026-10-05

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-856-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-856-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-856-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-856-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-856-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-856-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-856-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-856-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-856-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-856-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-856-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-856-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-856-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-856-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-856-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-856-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-856-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-856-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-856-30	2025-01-30	C162847	48780-1	2cef2736-8dcc-d83d-e063-dadaa90ab31f	HYDROXYZINE HCL 25mg
61919-856-60	2025-01-30	C162847	48780-1	2cef2736-8dcc-d83d-e063-dadaa90ab31f	HYDROXYZINE HCL 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-856-30	HYDROXYZINE HCL	30 in 1 BOTTLE	TABLET, FILM COATED	30		10
61919-856-60	HYDROXYZINE HCL	60 in 1 BOTTLE	TABLET, FILM COATED	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-856-30	EA - Each	61919-856	45acbc04-0d37-4de4-9582-94284af57054	1	2019-06-19
61919-856-60	EA - Each	61919-856	e1aa454d-f32d-4a14-9b26-9fc2421a3c1b	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-856	HYDROXYZINE HCL TABLET HYDROXYZINE HCL TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	10	Legacy NDC, 2 package rows	20230414_5cc3aaa6-e18f-a116-e053-2991aa0a1422.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	d03fdfd0-5dbd-40fe-a6e3-082a47751c2c	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	79f38cc2-f72f-3f30-e053-2991aa0ac540	2024-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	c59f24b5-0527-423a-ab14-db1ba1f7763f	2024-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	c2bce6a4-9feb-4816-a6d8-151e8ef3314d	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	e83de74d-b2e0-45c5-b072-170a96216d3a	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d618157e-f43f-4b31-ba5b-8a13a94885bc	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	49ee4ecf-b2c0-4301-89da-111e4d853168	2023-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d5d3ebf-e57e-4ed1-be97-d4b299fb738d	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	daefb617-209a-428b-9567-adc5880fa65c	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040602 application number: ANDA040602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	5cc3aaa6-e18f-a116-e053-2991aa0a1422	10
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	5cc3aaa6-e18f-a116-e053-2991aa0a1422	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-856-30	61919085630	30 TABLET, FILM COATED in 1 BOTTLE (61919-856-30)	2019-04-30	0000-00-00	No	No	Current
61919-856-60	61919085660	60 TABLET, FILM COATED in 1 BOTTLE (61919-856-60)	2019-04-30	0000-00-00	No	No	Current