Hydroxyzine Hydrochloride

Product NDC: 59651-500
Requested package NDC: 59651-500-81
11-digit product format: 596510500
Labeler code: 59651
Product ID: 59651-500_86a715f8-fbfb-4d28-a144-27581d6aa1bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA087871
Marketing category: ANDA
Marketing start: 2021-10-07
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing		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 1 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	59651-500	59651-500-81	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`

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
A087871-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20
A087871-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20
A087871-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087871-001	AB
A087871-002	AB
A087871-003	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	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1982-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1982-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087871-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1982-12-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 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	A087871-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087871-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087871-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087871-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087871-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087871-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087871-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087871-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087871-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087871-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087871-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087871-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087871-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087871-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087871-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087871-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087871-001	AB	1	`8072bd15b7f6…`

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	Bryant Ranch Prepack	f84e3365-57d2-4904-9275-96600f8d74c7	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aurobindo Pharma Limited	9de2de56-614f-4294-8794-d30758cf5f70	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871 ndc (product): 59651-500
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	56b49e5c-bb8a-46cd-873c-3c743d1653a4	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3526a66b-2182-4b5a-a7d1-563d75f5335f	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9504897e-febc-4293-a2dc-9f79f55ea821	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	eef36dab-c318-44d2-8583-7bae3bfceee7	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	fc148d96-b868-4e45-b7d2-977faf431049	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	a8c83479-f919-49f9-b125-747bd0e3211c	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	7c959515-a5a9-4d5e-90e9-bd58bc947330	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	138ec5c1-bb06-2a82-e063-6394a90ab42b	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087871 application number: ANDA087871

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76755771U3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995218	Internal RxNorm lookup
995258	Internal RxNorm lookup
995281	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9de2de56-614f-4294-8794-d30758cf5f70	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59651-500-01	Hydroxyzine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
59651-500-05	Hydroxyzine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
59651-500-99	Hydroxyzine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-500-01	EA - Each	59651-500	b2d77229-4342-451d-bc44-79e714cd4f56	1	2023-09-05
59651-500-05	EA - Each	59651-500	92b9842d-0aa0-4289-bb63-896903e2c4bb	1	2023-09-05
59651-500-99	EA - Each	59651-500	72d20174-f3f9-4782-81bd-3aed89954d7c	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-500	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	1	Current NDC, Legacy NDC, 3 package rows	20220811_9de2de56-614f-4294-8794-d30758cf5f70.zip

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	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	100
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	f84e3365-57d2-4904-9275-96600f8d74c7	100
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	e4e6a91d-f10b-4d85-a526-4c6192ea85dc	100
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	f84e3365-57d2-4904-9275-96600f8d74c7	100
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	9de2de56-614f-4294-8794-d30758cf5f70	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	9de2de56-614f-4294-8794-d30758cf5f70	2
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	9de2de56-614f-4294-8794-d30758cf5f70	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	9de2de56-614f-4294-8794-d30758cf5f70	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	9de2de56-614f-4294-8794-d30758cf5f70	2
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	9de2de56-614f-4294-8794-d30758cf5f70	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	eef36dab-c318-44d2-8583-7bae3bfceee7	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	eef36dab-c318-44d2-8583-7bae3bfceee7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
59651-500-81	59651050081	8000 TABLET, FILM COATED in 1 BAG (59651-500-81)	07-OCT-21	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	101
Hydroxyzine Hydrochloride Tablets, USP Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-03-03	Human Prescription Drug Label	2
Hydroxyzine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	100