HYDROXYZINE HYDROCHLORIDE

Product NDC: 67296-0648
11-digit product format: 672960648
Labeler code: 67296
Product ID: 67296-0648_9c9af7ee-602c-5314-e053-2995a90a8f25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040804
Marketing category: ANDA
Marketing start: 2008-06-30
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	67296-0648		I	Inactivated by FDA	2026-08-10
excluded product	product	67296-0648		I	Inactivated by FDA	2026-08-10
excluded package	package	67296-0648	67296-0648-1	I	Inactivated by FDA	2026-08-10
excluded package	package	67296-0648	67296-0648-2	I	Inactivated by FDA	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 80 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-0648-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-0648-1	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-0648-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-0648-1	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-0648-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-0648-1	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-0648-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-0648-1	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-0648-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-0648-1	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-0648-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-0648-1	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-0648-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-0648-1	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-0648-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-0648-1	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-0648-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-0648-1	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-0648-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-0648-1	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-0648-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-0648-1	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0648-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0648-1	`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 product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0648-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0648-1	`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 product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0648-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0648-1	`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 product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0648-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0648-1	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

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

Therapeutic equivalence codes#

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

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0648-2	2022-01-28	C162847	48780-1	d6a99b39-ba7e-a426-e053-dadaa90af4c2	4138311a-7764-3de5-e054-00144ff88e88
67296-0648-1	2020-01-31	C162847	48780-1	9d75b9d0-4ab9-f424-e053-dadaa90a57ce	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0648-2	HYDROXYZINE HYDROCHLORIDE	15 in 1 BOTTLE	TABLET, FILM COATED	15		7
67296-0648-1	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0648	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]	7	Legacy NDC, 1 package rows	20200123_4138311a-7764-3de5-e054-00144ff88e88.zip
67296-0648	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4	Legacy NDC, 1 package rows	20110727_42226ef6-7467-4fe8-8f07-4911c0b916af.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	934afb42-fee8-415b-8090-2265bb299afe	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040804 application number: ANDA040804

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	HYDROXYZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	4138311a-7764-3de5-e054-00144ff88e88	7
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	4138311a-7764-3de5-e054-00144ff88e88	7
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	42226ef6-7467-4fe8-8f07-4911c0b916af	4
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	42226ef6-7467-4fe8-8f07-4911c0b916af	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0648-1	67296064801	30 in 1 BOTTLE					Historical
67296-0648-2	67296064802	15 TABLET, FILM COATED in 1 BOTTLE (67296-0648-2)	2008-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	7
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	RedPharm Drug Inc. \| ANDAPharm LLC	2011-07-15	HUMAN PRESCRIPTION DRUG LABEL	4