Hydroxyzine Hydrochloride

Product NDC: 53002-3900
11-digit product format: 530023900
Labeler code: 53002
Product ID: 53002-3900_7e49822c-67af-4e66-a3bb-b13ce0feb92e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA088618
Marketing category: ANDA
Marketing start: 2012-10-09
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 25 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-3900		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-3900	53002-3900-1	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-3900	53002-3900-2	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-3900	53002-3900-3	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 · 68 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	53002-3900-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3900-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3900-3	`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	53002-3900-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3900-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3900-3	`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	53002-3900-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3900-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3900-3	`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	53002-3900-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3900-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3900-3	`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	53002-3900-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3900-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3900-3	`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	53002-3900-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3900-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3900-3	`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	53002-3900-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3900-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3900-3	`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	53002-3900-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3900-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3900-3	`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	53002-3900-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3900-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3900-3	`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	53002-3900-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-3900-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-3900-3	`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	53002-3900-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-3900-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-3900-3	`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	53002-3900-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-3900-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-3900-3	`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	53002-3900-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-3900-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-3900-3	`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	53002-3900-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-3900-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-3900-3	`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	53002-3900-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-3900-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-3900-3	`1332a3947898…`	`d4bfe170f9cd…`

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
A088618-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	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
A088618-001	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	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088618-001	HYDROXYZINE HYDROCHLORIDE	25MG	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	A088618-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088618-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088618-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088618-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088618-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088618-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088618-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088618-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088618-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088618-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088618-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088618-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088618-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088618-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088618-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088618-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088618-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088618-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088618-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088618-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088618-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088618-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088618-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088618-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088618-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088618-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088618-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088618-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088618-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088618-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088618-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088618-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088618-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088618-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088618-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088618-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088618-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088618-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088618-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088618-001	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, Related label table
NDC	Effective	Related label
53002-3900-1	2023-01-30	HydrOXYzine Hydrochloride Tablets USP
53002-3900-2	2023-01-30	HydrOXYzine Hydrochloride Tablets USP
53002-3900-3	2023-01-30	HydrOXYzine Hydrochloride Tablets USP
53002-3900-1	2020-12-16	HydrOXYzine Hydrochloride Tablets USP
53002-3900-2	2020-12-16	HydrOXYzine Hydrochloride Tablets USP
53002-3900-3	2020-12-16	HydrOXYzine Hydrochloride Tablets USP
53002-3900-1	2020-01-31	HydrOXYzine Hydrochloride Tablets USP
53002-3900-2	2020-01-31	HydrOXYzine Hydrochloride Tablets USP
53002-3900-3	2020-01-31	HydrOXYzine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-3900-1	Hydroxyzine Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	3
53002-3900-2	Hydroxyzine Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	3
53002-3900-3	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3900	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20201217_d307dc62-a7fb-4013-8f3c-28280e2d650b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	ca67c061-c743-4ebb-a9d5-ece488060663	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	b4d274ce-d616-4835-80ce-76270524ed36	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1767a886-ec92-39fb-e063-6294a90a1249	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	6ad55cd1-a284-4c3d-aa90-653704afdb75	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	db0dce55-5984-7580-e053-2a95a90a3695	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f90259a-a684-498f-8963-d02eaba2e9db	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b05bd0e-af57-4e74-92f8-a4311330142f	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	d79be126-39cd-4dbb-ad88-0e4c18109dda	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088618 application number: ANDA088618

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
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	d307dc62-a7fb-4013-8f3c-28280e2d650b	3
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	d307dc62-a7fb-4013-8f3c-28280e2d650b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3900-1	53002390001	10 TABLET, FILM COATED in 1 BOTTLE (53002-3900-1)	2018-10-01	0000-00-00	No	No	Current
53002-3900-2	53002390002	20 TABLET, FILM COATED in 1 BOTTLE (53002-3900-2)	2018-10-01	0000-00-00	No	No	Current
53002-3900-3	53002390003	30 TABLET, FILM COATED in 1 BOTTLE (53002-3900-3)	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Hydrochloride Tablets USP	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	3