hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-501
Product ID 59651-501_9de2de56-614f-4294-8794-d30758cf5f70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087871
Listing Expiration 2026-12-31
Marketing Start 2021-10-07

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651501
Hyphenated Format 59651-501

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 hydrochloride (source: ndc)
Application Number ANDA087871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-501-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (59651-501-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (59651-501-99)
source: ndc

Packages (3)

59651-501-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-501-01) 59651-501-05 500 TABLET, FILM COATED in 1 BOTTLE (59651-501-05) 59651-501-99 1000 TABLET, FILM COATED in 1 BOTTLE (59651-501-99)

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": "9de2de56-614f-4294-8794-d30758cf5f70", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["9de2de56-614f-4294-8794-d30758cf5f70"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-501-01)", "package_ndc": "59651-501-01", "marketing_start_date": "20211007"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59651-501-05)", "package_ndc": "59651-501-05", "marketing_start_date": "20211007"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (59651-501-99)", "package_ndc": "59651-501-99", "marketing_start_date": "20211007"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "59651-501_9de2de56-614f-4294-8794-d30758cf5f70", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "59651-501", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA087871", "marketing_category": "ANDA", "marketing_start_date": "20211007", "listing_expiration_date": "20261231"}