hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0365
Product ID 80425-0365_2a994dc6-72f8-0559-e063-6394a90a0ecf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2023-10-31

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250365
Hyphenated Format 80425-0365

Supplemental Identifiers

RxCUI
995258
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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0365-1)
  • 60 TABLET in 1 BOTTLE (80425-0365-2)
  • 90 TABLET in 1 BOTTLE (80425-0365-3)
source: ndc

Packages (3)

80425-0365-1 30 TABLET in 1 BOTTLE (80425-0365-1) 80425-0365-2 60 TABLET in 1 BOTTLE (80425-0365-2) 80425-0365-3 90 TABLET in 1 BOTTLE (80425-0365-3)

Ingredients (1)

hydroxyzine dihydrochloride (25 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": "2a994dc6-72f8-0559-e063-6394a90a0ecf", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["09092888-0c18-501d-e063-6294a90aad67"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0365-1)", "package_ndc": "80425-0365-1", "marketing_start_date": "20231031"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0365-2)", "package_ndc": "80425-0365-2", "marketing_start_date": "20231031"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0365-3)", "package_ndc": "80425-0365-3", "marketing_start_date": "20231031"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "80425-0365_2a994dc6-72f8-0559-e063-6394a90a0ecf", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "80425-0365", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20231031", "listing_expiration_date": "20261231"}