Hydroxyzine Hydrochloride

Product NDC: 21695-208
11-digit product format: 216950208
Labeler code: 21695
Product ID: 21695-208_48b10c63-5d7a-4841-9faa-17ac3d4873d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-208		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-208	21695-208-15	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-208	21695-208-20	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-208	21695-208-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-208	21695-208-60	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-208	21695-208-90	I	Inactivated by FDA	2026-10-05

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 3 · 132 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	21695-208-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-208-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-208-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-208-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-208-15	`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	21695-208-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-208-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-208-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-208-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-208-15	`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	21695-208-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-208-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-208-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-208-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-208-15	`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	21695-208-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-208-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-208-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-208-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-208-15	`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	21695-208-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-208-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-208-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-208-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-208-15	`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	21695-208-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-208-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-208-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-208-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-208-15	`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	21695-208-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-208-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-208-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-208-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-208-15	`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	21695-208-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-208-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-208-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-208-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-208-15	`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	21695-208-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-208-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-208-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-208-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-208-15	`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	21695-208-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-208-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-208-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-208-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-208-15	`ad56d346431e…`	`cc804d4bbf1e…`

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	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 · 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	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040804-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040804-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040804-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-06-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040804-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040804-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040804-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040804-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040804-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040804-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
21695-208-15	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
21695-208-20	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
21695-208-30	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
21695-208-60	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only
21695-208-90	HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-208-15	Hydroxyzine Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
21695-208-20	Hydroxyzine Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
21695-208-30	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
21695-208-60	Hydroxyzine Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
21695-208-90	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
21695-208-15	EA - Each	21695-208	7a70fb43-3c07-473b-8971-8633879ee854	1	2012-07-24
21695-208-20	EA - Each	21695-208	ac92210c-5014-4ebc-951b-61d4e716aa17	1	2012-07-24
21695-208-30	EA - Each	21695-208	3c86b585-6c75-4fe1-9e93-f4b00308db9f	1	2012-07-24
21695-208-60	EA - Each	21695-208	6e8b6caf-8fc9-4dd1-9b0d-0adb2e642964	1	2012-07-24
21695-208-90	EA - Each	21695-208	f4f7a16d-5745-4db3-8f3b-1250111cd845	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-208	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 5 package rows	20101201_48b10c63-5d7a-4841-9faa-17ac3d4873d1.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
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-208-15	21695020815	15 in 1 BOTTLE	Historical
21695-208-20	21695020820	20 in 1 BOTTLE	Historical
21695-208-30	21695020830	30 in 1 BOTTLE	Historical
21695-208-60	21695020860	60 in 1 BOTTLE	Historical
21695-208-90	21695020890	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	Rebel Distributors Corp	2010-09-29	HUMAN PRESCRIPTION DRUG LABEL	1