Hydroxyzine Hydrochloride

Product NDC: 17856-0150
Requested package NDC: 17856-0150-1
11-digit product format: 178560150
Labeler code: 17856
Product ID: 17856-0150_7e8e68b5-852c-4bc0-b9a9-f32772ee3dc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA087294
Marketing category: ANDA
Marketing start: 1995-03-09
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	17856-0150	17856-0150-1	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 1 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A087294-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087294-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`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	A087294-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087294-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087294-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087294-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087294-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087294-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087294-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087294-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087294-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087294-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087294-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087294-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087294-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087294-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087294-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087294-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087294-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087294-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087294-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087294-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087294-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087294-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087294-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087294-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087294-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087294-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087294-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087294-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087294-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087294-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087294-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087294-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087294-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087294-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087294-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087294-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087294-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087294-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087294-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087294-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
17856-0150-1	2023-01-30	C162847	48780-1	f386c649-9ffb-0266-e053-dadaa90a7c1a	HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP) 10 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0150-1	Hydroxyzine Hydrochloride	5 mL in 1 CUP	SYRUP	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0150	HYDROXYZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]	4	Legacy NDC, 1 package rows	20210128_25609c5f-953f-4434-938a-e3f01069893e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	0de7a377-7a8f-4119-b172-1eadb4b7e1be	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	53b2d731-f38a-47c0-9e5c-abd3b45e2fe1	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	bcddc5ce-6cfb-4a09-8e6c-c956b65e3188	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294

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
995241	hydrOXYzine HCl 10 MG in 5 mL Oral Solution	PSN	25609c5f-953f-4434-938a-e3f01069893e	4
995241	hydroxyzine hydrochloride 2 MG/ML Oral Solution	SCD	25609c5f-953f-4434-938a-e3f01069893e	4
995241	hydroxyzine hydrochloride 10 MG per 5 ML Oral Solution	SY	25609c5f-953f-4434-938a-e3f01069893e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0150-1	17856015001	5 mL in 1 CUP (17856-0150-1)	5 ml	2021-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP) 10 mg/5 mL	ATLANTIC BIOLOGICALS CORP.	2021-01-27	HUMAN PRESCRIPTION DRUG LABEL	4