hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler direct rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Direct Rx

Identifiers & Regulatory

Product NDC 72189-333
Product ID 72189-333_40817dfb-a4b8-2d36-e063-6394a90ac107
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2022-03-03

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189333
Hyphenated Format 72189-333

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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-333-30)
  • 120 TABLET in 1 BOTTLE (72189-333-72)
source: ndc

Packages (2)

72189-333-30 30 TABLET in 1 BOTTLE (72189-333-30) 72189-333-72 120 TABLET in 1 BOTTLE (72189-333-72)

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": "40817dfb-a4b8-2d36-e063-6394a90ac107", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218"], "spl_set_id": ["d956063a-ef48-faca-e053-2995a90a0291"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-333-30)", "package_ndc": "72189-333-30", "marketing_start_date": "20220303"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-333-72)", "package_ndc": "72189-333-72", "marketing_start_date": "20220303"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "72189-333_40817dfb-a4b8-2d36-e063-6394a90ac107", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "72189-333", "generic_name": "HYDROXYZINE HYDROCHLORIDE", "labeler_name": "Direct Rx", "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_start_date": "20220303", "listing_expiration_date": "20261231"}