levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride .5 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-680
Product ID 45802-680_1a939b38-64a2-4238-816d-4c01075e5cbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091263
Listing Expiration 2026-12-31
Marketing Start 2011-11-07

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 45802680
Hyphenated Format 45802-680

Supplemental Identifiers

RxCUI
855168
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 ANDA091263 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 148 mL in 1 BOTTLE (45802-680-28)
source: ndc

Packages (1)

45802-680-28 148 mL in 1 BOTTLE (45802-680-28)

Ingredients (1)

levocetirizine dihydrochloride (.5 mg/mL)

Linked Drug Pages (1)

levocetirizine dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a939b38-64a2-4238-816d-4c01075e5cbe", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855168"], "spl_set_id": ["2965ef46-18db-4615-9dce-bfb0f0b3366a"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "148 mL in 1 BOTTLE (45802-680-28)", "package_ndc": "45802-680-28", "marketing_start_date": "20111107"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "45802-680_1a939b38-64a2-4238-816d-4c01075e5cbe", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "45802-680", "generic_name": "Levocetirizine dihydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA091263", "marketing_category": "ANDA", "marketing_start_date": "20111107", "listing_expiration_date": "20261231"}