Hydroxyzine Hydrochloride

Product NDC: 71205-083
11-digit product format: 712050083
Labeler code: 71205
Product ID: 71205-083_6eebea17-bc98-49a2-854c-35267194f4c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA088619
Marketing category: ANDA
Marketing start: 2012-10-22
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A088619-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088619-001	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 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	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD	1986-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	1986-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088619-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	1986-01-10	`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	A088619-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088619-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088619-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088619-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088619-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088619-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088619-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088619-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088619-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088619-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088619-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088619-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088619-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088619-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088619-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088619-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088619-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088619-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088619-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088619-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088619-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088619-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088619-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088619-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088619-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088619-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088619-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088619-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088619-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088619-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088619-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088619-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088619-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088619-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088619-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088619-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088619-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088619-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088619-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088619-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
642ff329-c551-44f0-b340-49313db868c5	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
71205-083-15	Hydroxyzine Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	5
71205-083-20	Hydroxyzine Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
71205-083-30	Hydroxyzine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
71205-083-60	Hydroxyzine Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
71205-083-90	Hydroxyzine Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-083-15	EA - Each	71205-083	6a65c2ff-9660-41b2-a41d-fe17beb909c5	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-083	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 5 package rows	20221104_642ff329-c551-44f0-b340-49313db868c5.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northwind Health Company, LLC	f30879f6-d6e3-1f87-e053-2995a90abca9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine HCL	HYDROXYZINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	cd4ea0ea-0d92-b70c-e053-2995a90a62ce	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	642ff329-c551-44f0-b340-49313db868c5	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088619 application number: ANDA088619 ndc (product): 71205-083

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
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	642ff329-c551-44f0-b340-49313db868c5	5
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	642ff329-c551-44f0-b340-49313db868c5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-083-15	71205008315	15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15)	2018-08-01	0000-00-00	No	No	Current
71205-083-20	71205008320	20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20)	2018-08-01	0000-00-00	No	No	Current
71205-083-30	71205008330	30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30)	2018-08-01	0000-00-00	No	No	Current
71205-083-60	71205008360	60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60)	2018-08-01	0000-00-00	No	No	Current
71205-083-90	71205008390	90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)	2018-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Hydrochloride Tablets USP	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	5