Hydroxyzine Hydrochloride

Product NDC: 23155-106
11-digit product format: 231550106
Labeler code: 23155
Product ID: 23155-106_31945055-e1c9-4ecd-9ab0-944a377beefb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc.
Application: ANDA040804
Marketing category: ANDA
Marketing start: 2008-06-30
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-106-01	EA - Each	23155-106	1bb34437-90bc-446b-9814-845b3bc195cd	1	2012-07-24
23155-106-05	EA - Each	23155-106	af114e72-60bf-4ca1-9bf9-e736ae7d9e73	1	2012-07-24
23155-106-10	EA - Each	23155-106	2e74f689-47ae-4d2b-84db-1e62f88c069e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	3
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	2
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

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	4138311a-7764-3de5-e054-00144ff88e88	7
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	4138311a-7764-3de5-e054-00144ff88e88	7
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	71933574-d1fb-4952-acc9-fc345f324756	4
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	71933574-d1fb-4952-acc9-fc345f324756	4
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	42226ef6-7467-4fe8-8f07-4911c0b916af	4
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	71933574-d1fb-4952-acc9-fc345f324756	4
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	71933574-d1fb-4952-acc9-fc345f324756	4
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	42226ef6-7467-4fe8-8f07-4911c0b916af	4
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	71933574-d1fb-4952-acc9-fc345f324756	4
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	71933574-d1fb-4952-acc9-fc345f324756	4
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	80833d7f-8a36-470a-b7ba-6343549e2273	3
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	80833d7f-8a36-470a-b7ba-6343549e2273	3
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	06555ff6-ddfb-4373-9853-9860557e376e	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	0f71b078-a957-47ed-a235-922c27c9a621	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	06555ff6-ddfb-4373-9853-9860557e376e	2
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	02aee05a-2e3b-4a2f-85e7-8cbadd667a85	2
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	06555ff6-ddfb-4373-9853-9860557e376e	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	02aee05a-2e3b-4a2f-85e7-8cbadd667a85	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	0f71b078-a957-47ed-a235-922c27c9a621	2
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	06555ff6-ddfb-4373-9853-9860557e376e	2
995218	hydrOXYzine HCl 10 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995258	hydrOXYzine HCl 25 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995281	hydrOXYzine HCl 50 MG Oral Tablet	PSN	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995218	hydroxyzine hydrochloride 10 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995258	hydroxyzine hydrochloride 25 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1
995281	hydroxyzine hydrochloride 50 MG Oral Tablet	SCD	48b10c63-5d7a-4841-9faa-17ac3d4873d1	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYZINE HYDROCHLORIDE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	7
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	Unit Dose Services	2016-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROXYZINE HYDROCHLORIDE	DIRECT RX	2015-08-06	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROXYZINE HYDROCHLORIDE	Northwind Pharmaceuticals, LLC	2015-04-01	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	Blenheim Pharmacal, Inc.	2015-03-20	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxyzine Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2013-02-19	HUMAN PRESCRIPTION DRUG LABEL	4
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	H.J. Harkins Company, Inc.	2012-01-23	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	RedPharm Drug Inc. \| ANDAPharm LLC	2011-07-15	HUMAN PRESCRIPTION DRUG LABEL	4
HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only	Rebel Distributors Corp	2010-09-29	HUMAN PRESCRIPTION DRUG LABEL	1

Hydroxyzine Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#