hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2410
Product ID 71335-2410_628ecb39-d59f-44d7-8d84-6dd5d31407c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217652
Listing Expiration 2026-12-31
Marketing Start 2023-08-22

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352410
Hyphenated Format 71335-2410

Supplemental Identifiers

RxCUI
995281
UNII
76755771U3

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyzine hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA217652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-2410-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-2410-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2410-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-2410-4)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2410-5)
source: ndc

Packages (5)

71335-2410-1 120 TABLET, FILM COATED in 1 BOTTLE (71335-2410-1) 71335-2410-2 20 TABLET, FILM COATED in 1 BOTTLE (71335-2410-2) 71335-2410-3 30 TABLET, FILM COATED in 1 BOTTLE (71335-2410-3) 71335-2410-4 60 TABLET, FILM COATED in 1 BOTTLE (71335-2410-4) 71335-2410-5 90 TABLET, FILM COATED in 1 BOTTLE (71335-2410-5)

Ingredients (1)

hydroxyzine dihydrochloride (50 mg/1)

Linked Drug Pages (1)

HYDROXYZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "628ecb39-d59f-44d7-8d84-6dd5d31407c1", "openfda": {"unii": ["76755771U3"], "rxcui": ["995281"], "spl_set_id": ["4b8614d9-335c-4141-aaed-445c604ba08c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-2410-1)", "package_ndc": "71335-2410-1", "marketing_start_date": "20240610"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-2410-2)", "package_ndc": "71335-2410-2", "marketing_start_date": "20240610"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2410-3)", "package_ndc": "71335-2410-3", "marketing_start_date": "20240610"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2410-4)", "package_ndc": "71335-2410-4", "marketing_start_date": "20240610"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2410-5)", "package_ndc": "71335-2410-5", "marketing_start_date": "20240610"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "71335-2410_628ecb39-d59f-44d7-8d84-6dd5d31407c1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71335-2410", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217652", "marketing_category": "ANDA", "marketing_start_date": "20230822", "listing_expiration_date": "20261231"}