hydroxyzine hcl

Generic: hydroxyzine hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hcl
Generic Name hydroxyzine hcl
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-577
Product ID 72189-577_22049012-733f-6b45-e063-6294a90a670f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217652
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189577
Hyphenated Format 72189-577

Supplemental Identifiers

RxCUI
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 hcl (source: ndc)
Generic Name hydroxyzine hcl (source: ndc)
Application Number ANDA217652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-577-60)
source: ndc

Packages (1)

72189-577-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-577-60)

Ingredients (1)

hydroxyzine dihydrochloride (50 mg/1)

Linked Drug Pages (1)

Hydroxyzine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22049012-733f-6b45-e063-6294a90a670f", "openfda": {"unii": ["76755771U3"], "rxcui": ["995281"], "spl_set_id": ["22049012-733e-6b45-e063-6294a90a670f"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-577-60)", "package_ndc": "72189-577-60", "marketing_start_date": "20240913"}], "brand_name": "Hydroxyzine HCL", "product_id": "72189-577_22049012-733f-6b45-e063-6294a90a670f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "72189-577", "generic_name": "Hydroxyzine HCL", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine HCL", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217652", "marketing_category": "ANDA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}