hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler proficient rx lp
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-494
Product ID 63187-494_ee6acff5-b3af-457d-bc54-b822635405a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087294
Listing Expiration 2026-12-31
Marketing Start 1995-03-09

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187494
Hyphenated Format 63187-494

Supplemental Identifiers

RxCUI
995241
UPC
0363187494049
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 ANDA087294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (63187-494-04)
source: ndc

Packages (1)

63187-494-04 118 mL in 1 BOTTLE, PLASTIC (63187-494-04)

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": "ee6acff5-b3af-457d-bc54-b822635405a3", "openfda": {"upc": ["0363187494049"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["bcddc5ce-6cfb-4a09-8e6c-c956b65e3188"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (63187-494-04)", "package_ndc": "63187-494-04", "marketing_start_date": "20150202"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "63187-494_ee6acff5-b3af-457d-bc54-b822635405a3", "dosage_form": "SYRUP", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "63187-494", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA087294", "marketing_category": "ANDA", "marketing_start_date": "19950309", "listing_expiration_date": "20261231"}