Hydroxyzine Hydrochloride

Product NDC: 10544-227
11-digit product format: 105440227
Labeler code: 10544
Product ID: 10544-227_31a005d8-7b61-4cac-bac5-78b0c09d46ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA040808
Marketing category: ANDA
Marketing start: 2013-11-18
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-227		I	Inactivated by FDA	2026-09-14
excluded package	package	10544-227	10544-227-30	I	Inactivated by FDA	2026-09-14
excluded package	package	10544-227	10544-227-90	I	Inactivated by FDA	2026-09-14

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 2 · 66 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	10544-227-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-227-30	`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	10544-227-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-227-30	`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	10544-227-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-227-30	`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	10544-227-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-227-30	`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	10544-227-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-227-30	`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	10544-227-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-227-30	`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	10544-227-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-227-30	`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	10544-227-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-227-30	`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	10544-227-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-227-30	`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	10544-227-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-227-30	`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	10544-227-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-227-30	`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	10544-227-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-227-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-227-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-227-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-227-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-227-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-227-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-227-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-227-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-227-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-227-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-227-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-227-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-227-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-227-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-227-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-227-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-227-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A040808-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-09-24
A040808-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-09-24
A040808-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-09-24

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 · 129 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
2026-09-14 22:38:34	2026-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A040808-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040808-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040808-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040808-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040808-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040808-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040808-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040808-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040808-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040808-001	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
10544-227-30	2019-11-27	C162847	48780-1	9855e2a2-3768-60a7-e053-dbdaa90a05bd	HYDROXYZINE HYDROCHLORIDE TABLETS, USP
10544-227-90	2019-11-27	C162847	48780-1	9855e2a2-3768-60a7-e053-dbdaa90a05bd	HYDROXYZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-227-30	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
10544-227-90	Hydroxyzine Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-227-30	EA - Each	10544-227	ee128470-8080-468b-b2dc-0020c6180d35	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-227	HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20140205_31a005d8-7b61-4cac-bac5-78b0c09d46ca.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	Amneal Pharmaceuticals LLC	89901966-724b-4773-98b8-ea663ceabd53	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040808 application number: ANDA040808

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	HYDROXYZINE HYDROCHLORIDE
30S50YM8OG	HYDROXYZINE	68-88-2	Hydroxyzine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	31a005d8-7b61-4cac-bac5-78b0c09d46ca	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	31a005d8-7b61-4cac-bac5-78b0c09d46ca	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	31a005d8-7b61-4cac-bac5-78b0c09d46ca	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	31a005d8-7b61-4cac-bac5-78b0c09d46ca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-227-30	10544022730	30 in 1 BOTTLE	Historical
10544-227-90	10544022790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE TABLETS, USP	Blenheim Pharmacal, Inc.	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	1