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, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-547
Product ID 62135-547_258a2adf-df42-7a34-e063-6294a90a84ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040804
Listing Expiration 2026-12-31
Marketing Start 2008-06-30

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135547
Hyphenated Format 62135-547

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0362135545055 0362135545123 0362135547059 0362135546052 0362135546120 0362135547127
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 ANDA040804 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (62135-547-05)
  • 120 TABLET, FILM COATED in 1 BOTTLE (62135-547-12)
source: ndc

Packages (2)

62135-547-05 500 TABLET, FILM COATED in 1 BOTTLE (62135-547-05) 62135-547-12 120 TABLET, FILM COATED in 1 BOTTLE (62135-547-12)

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": "258a2adf-df42-7a34-e063-6294a90a84ca", "openfda": {"upc": ["0362135545055", "0362135545123", "0362135547059", "0362135546052", "0362135546120", "0362135547127"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["934afb42-fee8-415b-8090-2265bb299afe"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62135-547-05)", "package_ndc": "62135-547-05", "marketing_start_date": "20230628"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (62135-547-12)", "package_ndc": "62135-547-12", "marketing_start_date": "20230628"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "62135-547_258a2adf-df42-7a34-e063-6294a90a84ca", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "62135-547", "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": "ANDA040804", "marketing_category": "ANDA", "marketing_start_date": "20080630", "listing_expiration_date": "20261231"}