HYDROXYZINE HYDROCHLORIDE

Product NDC: 71335-2410
11-digit product format: 713352410
Labeler code: 71335
Product ID: 71335-2410_628ecb39-d59f-44d7-8d84-6dd5d31407c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA217652
Marketing category: ANDA
Marketing start: 2023-08-22
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

openFDA Listing Details

Product ID: 71335-2410_628ecb39-d59f-44d7-8d84-6dd5d31407c1
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: HYDROXYZINE HYDROCHLORIDE
Generic name: hydroxyzine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2023-08-22
Marketing category: ANDA
Application number: ANDA217652
Pharmacologic classes: Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	50 mg/1

UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	hydroxyzine hydrochloride

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2410-1	71335241001	120 TABLET, FILM COATED in 1 BOTTLE (71335-2410-1)	2024-06-10	No	No	Current
71335-2410-2	71335241002	20 TABLET, FILM COATED in 1 BOTTLE (71335-2410-2)	2024-06-10	No	No	Current
71335-2410-3	71335241003	30 TABLET, FILM COATED in 1 BOTTLE (71335-2410-3)	2024-06-10	No	No	Current
71335-2410-4	71335241004	60 TABLET, FILM COATED in 1 BOTTLE (71335-2410-4)	2024-06-10	No	No	Current
71335-2410-5	71335241005	90 TABLET, FILM COATED in 1 BOTTLE (71335-2410-5)	2024-06-10	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	1