hydroxyzine hydrochloride

Generic: hydroxyzine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-577
Product ID 65162-577_6c929cf4-2a16-4956-b410-8e44db920604
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040808
Listing Expiration 2026-12-31
Marketing Start 2008-09-24

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162577
Hyphenated Format 65162-577

Supplemental Identifiers

RxCUI
995218 995258 995281
UNII
76755771U3

Packaging Origin

Original Packager
true

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 (source: ndc)
Application Number ANDA040808 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65162-577-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65162-577-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-577-50)
source: ndc

Packages (3)

65162-577-10 100 TABLET, FILM COATED in 1 BOTTLE (65162-577-10) 65162-577-11 1000 TABLET, FILM COATED in 1 BOTTLE (65162-577-11) 65162-577-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-577-50)

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": "6c929cf4-2a16-4956-b410-8e44db920604", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["89901966-724b-4773-98b8-ea663ceabd53"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65162-577-10)", "package_ndc": "65162-577-10", "marketing_start_date": "20080924"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65162-577-11)", "package_ndc": "65162-577-11", "marketing_start_date": "20080924"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-577-50)", "package_ndc": "65162-577-50", "marketing_start_date": "20080924"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "65162-577_6c929cf4-2a16-4956-b410-8e44db920604", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "65162-577", "generic_name": "Hydroxyzine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040808", "marketing_category": "ANDA", "marketing_start_date": "20080924", "listing_expiration_date": "20261231"}