hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride oral

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride oral
Labeler bionpharma inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-395
Product ID 69452-395_39f93640-6535-6c3b-e063-6394a90a7f2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219289
Listing Expiration 2026-12-31
Marketing Start 2025-07-17

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452395
Hyphenated Format 69452-395

Supplemental Identifiers

RxCUI
995241
UPC
0369452395882
UNII
76755771U3

Packaging Origin

Original Packager
true

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 oral (source: ndc)
Application Number ANDA219289 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69452-395-88)
source: ndc

Packages (1)

69452-395-88 473 mL in 1 BOTTLE (69452-395-88)

Ingredients (1)

hydroxyzine dihydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Hydroxyzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39f93640-6535-6c3b-e063-6394a90a7f2d", "openfda": {"upc": ["0369452395882"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["39f93633-000e-6c3f-e063-6394a90a5a0b"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69452-395-88)", "package_ndc": "69452-395-88", "marketing_start_date": "20250717"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "69452-395_39f93640-6535-6c3b-e063-6394a90a7f2d", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "69452-395", "generic_name": "Hydroxyzine Hydrochloride Oral", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA219289", "marketing_category": "ANDA", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}