hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-575
Product ID 62135-575_459c9507-ea13-81b1-e063-6394a90a3db4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2014-08-20

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135575
Hyphenated Format 62135-575

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0362135575052 0362135574055 0362135573126 0362135573058 0362135575120 0362135574123
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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (62135-575-05)
  • 120 TABLET in 1 BOTTLE (62135-575-12)
source: ndc

Packages (2)

62135-575-05 500 TABLET in 1 BOTTLE (62135-575-05) 62135-575-12 120 TABLET in 1 BOTTLE (62135-575-12)

Ingredients (1)

hydroxyzine dihydrochloride (50 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": "459c9507-ea13-81b1-e063-6394a90a3db4", "openfda": {"upc": ["0362135575052", "0362135574055", "0362135573126", "0362135573058", "0362135575120", "0362135574123"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["6533bb4f-efbc-4fca-b625-daa1b3978740"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (62135-575-05)", "package_ndc": "62135-575-05", "marketing_start_date": "20230411"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (62135-575-12)", "package_ndc": "62135-575-12", "marketing_start_date": "20230411"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "62135-575_459c9507-ea13-81b1-e063-6394a90a3db4", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "62135-575", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20140820", "listing_expiration_date": "20261231"}