levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-238
Product ID 69367-238_173f9840-08fa-4972-a624-0c716356d7ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203646
Listing Expiration 2026-12-31
Marketing Start 2019-09-19

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367238
Hyphenated Format 69367-238

Supplemental Identifiers

RxCUI
855172
UPC
0369367238090
UNII
SOD6A38AGA

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 levocetirizine dihydrochloride (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number ANDA203646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (69367-238-09)
source: ndc

Packages (1)

69367-238-09 90 TABLET in 1 BOTTLE, PLASTIC (69367-238-09)

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

Levocetirizine Dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "173f9840-08fa-4972-a624-0c716356d7ee", "openfda": {"upc": ["0369367238090"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["85dcd6c0-7fb2-40b3-b07f-93bab169011d"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (69367-238-09)", "package_ndc": "69367-238-09", "marketing_start_date": "20190919"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "69367-238_173f9840-08fa-4972-a624-0c716356d7ee", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69367-238", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203646", "marketing_category": "ANDA", "marketing_start_date": "20190919", "listing_expiration_date": "20261231"}