HYDROXYZINE HCL

Product NDC: 61919-646
Requested package NDC: 61919-646-30
11-digit product format: 619190646
Labeler code: 61919
Product ID: 61919-646_9c9742a4-a21f-3605-e053-2995a90a2989
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA040804
Marketing category: ANDA
Marketing start: 2016-02-12
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61919-646	61919-646-30	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040804-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30
A040804-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30
A040804-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040804-001	AB
A040804-002	AB
A040804-003	AB

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040804-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040804-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040804-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040804-001	AB	1	`8072bd15b7f6…`

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
61919-646-30	2023-01-30	C162847	48780-1	f386c64a-45a5-0266-e053-dadaa90a7c1a	HYDROXYZINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-646-30	HYDROXYZINE HCL	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-646	HYDROXYZINE HCL TABLET, FILM COATED [DIRECT RX]	2	Legacy NDC, 1 package rows	20200130_2bd1350a-5bb5-33c1-e054-00144ff88e88.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	Chartwell RX, LLC	934afb42-fee8-415b-8090-2265bb299afe	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040804 application number: ANDA040804

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
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	2bd1350a-5bb5-33c1-e054-00144ff88e88	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	2bd1350a-5bb5-33c1-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-646-30	61919064630	30 TABLET, FILM COATED in 1 BOTTLE (61919-646-30)	2016-02-12	0000-00-00	No	No	Current