HYDROXYZINE HYDROCHLORIDE

Product NDC: 52959-481
11-digit product format: 529590481
Labeler code: 52959
Product ID: 52959-481_5f140045-e8ea-28c2-e053-2991aa0a46cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: H.J Harkins Company inc.
Application: ANDA204279
Marketing category: ANDA
Marketing start: 2017-01-03
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: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-481		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-06	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-10	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-12	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-20	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-25	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-481	52959-481-60	I	Inactivated by FDA	2026-08-03

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 4 · 189 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	52959-481-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-481-60	`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	52959-481-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-481-60	`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	52959-481-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-481-60	`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	52959-481-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-481-60	`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	52959-481-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-481-60	`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	52959-481-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-481-60	`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	52959-481-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-481-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-481-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-481-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-481-30	`302b2466d912…`	`e7b80fea0513…`

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
A204279-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20
A204279-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20
A204279-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204279-001	AB
A204279-002	AB
A204279-003	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	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204279-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-20	`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	A204279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204279-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204279-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204279-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204279-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204279-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204279-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204279-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204279-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204279-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204279-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204279-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204279-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204279-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204279-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204279-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204279-001	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, Related label table
NDC	Related label
52959-481-06	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-10	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-12	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-15	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-20	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-25	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-30	5f140045-e8e9-28c2-e053-2991aa0a46cc
52959-481-60	5f140045-e8e9-28c2-e053-2991aa0a46cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-481-06	HYDROXYZINE HYDROCHLORIDE	6 in 1 CONTAINER	TABLET	6	1
52959-481-10	HYDROXYZINE HYDROCHLORIDE	10 in 1 CONTAINER	TABLET	10	1
52959-481-12	HYDROXYZINE HYDROCHLORIDE	12 in 1 CONTAINER	TABLET	12	1
52959-481-15	HYDROXYZINE HYDROCHLORIDE	15 in 1 CONTAINER	TABLET	15	1
52959-481-20	HYDROXYZINE HYDROCHLORIDE	20 in 1 CONTAINER	TABLET	20	1
52959-481-25	HYDROXYZINE HYDROCHLORIDE	25 in 1 CONTAINER	TABLET	25	1
52959-481-30	HYDROXYZINE HYDROCHLORIDE	30 in 1 CONTAINER	TABLET	30	1
52959-481-60	HYDROXYZINE HYDROCHLORIDE	60 in 1 CONTAINER	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-481-10	EA - Each	52959-481	313c3b23-58f1-427e-885b-8e8e03a257c0	1	2017-12-14
52959-481-12	EA - Each	52959-481	fa46d4bb-d7eb-49ab-8b4e-43a060a2ee5c	1	2017-12-14
52959-481-20	EA - Each	52959-481	d99553f3-2c9a-4bbb-a1fe-4e221d981856	1	2017-12-14
52959-481-30	EA - Each	52959-481	ff9190cb-8cb8-4538-aa7b-d008329a445e	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-481	HYDROXYZINE HYDROCHLORIDE TABLET [H.J HARKINS COMPANY INC.]	1	Legacy NDC, 8 package rows	20171206_5f140045-e8e9-28c2-e053-2991aa0a46cc.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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7f76580c-96a0-4b56-8986-ff5488bb9869	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	bb4a7d22-2f42-4e9f-bf98-cee43ed14d50	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	c8b441bf-a03e-47b3-8f06-c347f5ca4b70	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	b6189074-e199-4f58-a78d-c04f131c13d9	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	83e8d60d-36fd-4223-b50c-e6615045352a	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5506e802-0efc-a845-e063-6394a90aad0e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Incl	63fdf791-1a58-45ba-8ef2-15b80bb24f23	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Coupler LLC	508848a5-017c-dd3e-e063-6294a90a456b	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4cd84205-6a33-db48-e063-6394a90a9182	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	71eea118-395c-4559-aed5-900b635674b8	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	1350964e-663e-4a50-8c4c-cda371a694a0	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	4c2c4d8e-c3d1-48c7-8f99-ffa159667465	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b3d10f-2599-5b71-e053-2a95a90a54bb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c134195e-a048-530a-e053-2a95a90ad9f8	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	c13455a3-3078-4fe1-e053-2a95a90adf8e	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	6533bb4f-efbc-4fca-b625-daa1b3978740	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Direct Rx	d956063a-ef48-faca-e053-2995a90a0291	2025-10-06		Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ca015a35-1f94-4f92-9143-3f149982d316	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	2fc9b08a-e675-dbc5-e063-6294a90ad054	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204279 application number: ANDA204279

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	5f140045-e8e9-28c2-e053-2991aa0a46cc	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	5f140045-e8e9-28c2-e053-2991aa0a46cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-481-06	52959048106	6 in 1 CONTAINER	Historical
52959-481-10	52959048110	10 in 1 CONTAINER	Historical
52959-481-12	52959048112	12 in 1 CONTAINER	Historical
52959-481-15	52959048115	15 in 1 CONTAINER	Historical
52959-481-20	52959048120	20 in 1 CONTAINER	Historical
52959-481-25	52959048125	25 in 1 CONTAINER	Historical
52959-481-30	52959048130	30 in 1 CONTAINER	Historical
52959-481-60	52959048160	60 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE - H.J Harkins Company inc. \| H. J. Harkins Company Inc.	H.J Harkins Company inc. \| H. J. Harkins Company Inc.	2017-11-28	HUMAN PRESCRIPTION DRUG LABEL	1