hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1034
Product ID 0121-1034_44c48714-8f0c-4628-9783-ff32360b457d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040391
Listing Expiration 2026-12-31
Marketing Start 2002-04-10

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211034
Hyphenated Format 0121-1034

Supplemental Identifiers

RxCUI
995241
UPC
0301211034168
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 (source: ndc)
Application Number ANDA040391 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0121-1034-16)
source: ndc

Packages (1)

0121-1034-16 473 mL in 1 BOTTLE (0121-1034-16)

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": "44c48714-8f0c-4628-9783-ff32360b457d", "openfda": {"upc": ["0301211034168"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["2a343906-0bea-4bd8-bd35-c3f199d9b266"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0121-1034-16)", "package_ndc": "0121-1034-16", "marketing_start_date": "20241114"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "0121-1034_44c48714-8f0c-4628-9783-ff32360b457d", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0121-1034", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA040391", "marketing_category": "ANDA", "marketing_start_date": "20020410", "listing_expiration_date": "20261231"}