HYDROXYZINE HYDROCHLORIDE

Product NDC: 10135-811
11-digit product format: 101350811
Labeler code: 10135
Product ID: 10135-811_31a907fc-2be0-1219-e063-6294a90ac00f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA207121
Marketing category: ANDA
Marketing start: 2025-03-01
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 25 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207121-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29
A207121-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29
A207121-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207121-001	AB
A207121-002	AB
A207121-003	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 3 · 115 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	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	A207121-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207121-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207121-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207121-001	AB	1	`8072bd15b7f6…`

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	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
31a907e6-7fae-0682-e063-6294a90a24a5	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	Strength	SPL version
10135-811-01	HYDROXYZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		1
10135-811-10	HYDROXYZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-811-01	EA - Each	10135-811	c151b084-6efd-4040-8dc1-76785430d02f	1	2025-06-13
10135-811-10	EA - Each	10135-811	42fdb0f5-8745-4450-bb7f-5c83fee1e5f8	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-811	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20250403_31a907e6-7fae-0682-e063-6294a90a24a5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	31a907e6-7fae-0682-e063-6294a90a24a5	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207121 application number: ANDA207121 ndc (product): 10135-811
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Sunrise Pharmaceutical, Inc.	94561525-a565-4193-b64d-e1459ab05678	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207121 application number: ANDA207121

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	31a907e6-7fae-0682-e063-6294a90a24a5	1
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	31a907e6-7fae-0682-e063-6294a90a24a5	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	31a907e6-7fae-0682-e063-6294a90a24a5	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	31a907e6-7fae-0682-e063-6294a90a24a5	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	31a907e6-7fae-0682-e063-6294a90a24a5	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	31a907e6-7fae-0682-e063-6294a90a24a5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
10135-811-01	10135081101	100 TABLET, FILM COATED in 1 BOTTLE (10135-811-01)	2025-03-01	No	No	Current
10135-811-10	10135081110	1000 TABLET, FILM COATED in 1 BOTTLE (10135-811-10)	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets, USP	Marlex Pharmaceuticals, Inc.	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	1