HYDROXYZINE HYDROCHLORIDE

Product NDC: 13668-582
Requested package NDC: 13668-582-10
11-digit product format: 136680582
Labeler code: 13668
Product ID: 13668-582_d91b8366-0757-47c3-e053-2995a90a05c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA210634
Marketing category: ANDA
Marketing start: 2019-02-26
Marketing end: 0000-00-00
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13668-582	13668-582-10	D	Discontinued by firm		2026-08-07

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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A210634-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2019-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210634-001	AA

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210634-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		2019-02-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210634-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210634-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210634-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210634-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210634-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210634-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210634-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210634-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210634-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210634-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210634-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210634-001	AA	1	`301d65b070ca…`
2019-12-13 00:20 UTC	2019-12	A210634-001	AA	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A210634-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210634-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210634-001	AA	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13668-582-10	2021-11-12	C162847	48780-1	ba0f9c33-1b41-a910-e053-dadaa90a0b85	Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL Rx only
13668-582-10	2021-01-29	C162847	48780-1	ba0f9c33-1b41-a910-e053-dadaa90a0b85	Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL Rx only

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	APOZEAL PHARMACEUTICALS INC	87d4bbff-0498-4c26-86cb-7ce173afa0b6	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210634 application number: ANDA210634

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-582-10	13668058210	473 mL in 1 BOTTLE (13668-582-10)	473 ml	2019-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL Rx only	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Torrent Pharma Inc	2022-02-28	HUMAN PRESCRIPTION DRUG LABEL	6