Hydroxyzine

Product NDC: 10544-209
11-digit product format: 105440209
Labeler code: 10544
Product ID: 10544-209_d360cdb2-78e7-45b3-a06a-6f19e2224a58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA088617
Marketing category: ANDA
Marketing start: 2009-12-28
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 10 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	10544-209		I	Inactivated by FDA	2026-08-03
excluded package	package	10544-209	10544-209-15	I	Inactivated by FDA	2026-08-03
excluded package	package	10544-209	10544-209-30	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 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	10544-209-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-209-15	`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	10544-209-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-209-15	`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	10544-209-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-209-15	`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	10544-209-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-209-15	`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	10544-209-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-209-15	`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	10544-209-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-209-15	`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	10544-209-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-209-15	`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	10544-209-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-209-15	`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	10544-209-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-209-15	`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	10544-209-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-209-15	`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	10544-209-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-209-15	`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	10544-209-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-209-15	`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	10544-209-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-209-15	`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	10544-209-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-209-15	`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	10544-209-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-209-15	`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	10544-209-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-209-15	`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	10544-209-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-209-15	`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	10544-209-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-209-15	`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	10544-209-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-209-15	`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	10544-209-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-209-15	`e2bbac7714bc…`	`27bdfed8d636…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088617-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088617-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088617-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A088617-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088617-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088617-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088617-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088617-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088617-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088617-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088617-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088617-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088617-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088617-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088617-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088617-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088617-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088617-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088617-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088617-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088617-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088617-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088617-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088617-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088617-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088617-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088617-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088617-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088617-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088617-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088617-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088617-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088617-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088617-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088617-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088617-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088617-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088617-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088617-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088617-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088617-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088617-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088617-001	AB	1	`cb3db0bc1861…`

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
10544-209-15	2019-10-29	C162847	48780-1	960f7f55-c272-8e05-e053-dbdaa90a074a	HYDROXYZINE HYDROCHLORIDE TABLETS USP
10544-209-30	2019-10-29	C162847	48780-1	960f7f55-c272-8e05-e053-dbdaa90a074a	HYDROXYZINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-209-15	Hydroxyzine	15 in 1 BOTTLE	TABLET, FILM COATED	15		1
10544-209-30	Hydroxyzine	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-209-15	EA - Each	10544-209	b13af2b9-0a89-4943-a387-16da5092353b	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	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
10544-209	HYDROXYZINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20101007_a49c7e1a-ed02-439a-9b02-bef7d86ed464.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St Mary's Medical Park Pharmacy	9ef6a4b7-362d-61b4-e053-2995a90a0ebb	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7165a30c-09e4-4ca1-8548-bf71998ba12f	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	714a26a1-371f-ef23-e053-2a95a90a6af6	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3946db7c-dc2d-4329-b9ac-f003d8c6d3e1	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088617 application number: ANDA088617

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
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	a49c7e1a-ed02-439a-9b02-bef7d86ed464	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	a49c7e1a-ed02-439a-9b02-bef7d86ed464	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-209-15	10544020915	15 in 1 BOTTLE	Historical
10544-209-30	10544020930	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE TABLETS USP	Blenheim Pharmacal, Inc.	2010-10-06	HUMAN PRESCRIPTION DRUG LABEL	1