hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4117
Product ID 50090-4117_1018a246-77e1-446e-b436-30feac311856
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088617
Listing Expiration 2026-12-31
Marketing Start 2013-02-19

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904117
Hyphenated Format 50090-4117

Supplemental Identifiers

RxCUI
995218
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 ANDA088617 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4117-0)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4117-3)
source: ndc

Packages (2)

50090-4117-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-4117-0) 50090-4117-3 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4117-3)

Ingredients (1)

hydroxyzine dihydrochloride (10 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": "1018a246-77e1-446e-b436-30feac311856", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218"], "spl_set_id": ["3946db7c-dc2d-4329-b9ac-f003d8c6d3e1"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4117-0)", "package_ndc": "50090-4117-0", "marketing_start_date": "20190201"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4117-3)", "package_ndc": "50090-4117-3", "marketing_start_date": "20141128"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "50090-4117_1018a246-77e1-446e-b436-30feac311856", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "50090-4117", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA088617", "marketing_category": "ANDA", "marketing_start_date": "20130219", "listing_expiration_date": "20261231"}