hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7377
Product ID 0904-7377_462940f7-5dba-4ca2-829d-e0a8a72579e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Marketing Start 2023-08-01
Marketing End 2026-04-30

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047377
Hyphenated Format 0904-7377

Supplemental Identifiers

RxCUI
995218 995258 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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (0904-7377-40)
source: ndc

Packages (1)

0904-7377-40 500 TABLET in 1 BOTTLE (0904-7377-40)

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": "462940f7-5dba-4ca2-829d-e0a8a72579e5", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["7f76580c-96a0-4b56-8986-ff5488bb9869"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (0904-7377-40)", "package_ndc": "0904-7377-40", "marketing_end_date": "20260430", "marketing_start_date": "20230801"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "0904-7377_462940f7-5dba-4ca2-829d-e0a8a72579e5", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0904-7377", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20230801"}