levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8810
Product ID 68788-8810_5d6941c7-ef0a-48d3-93dc-53bc2c9789de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205564
Listing Expiration 2026-12-31
Marketing Start 2025-01-20

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 687888810
Hyphenated Format 68788-8810

Supplemental Identifiers

RxCUI
855172
UNII
SOD6A38AGA

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 ANDA205564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8810-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8810-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8810-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8810-9)
source: ndc

Packages (4)

68788-8810-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8810-1) 68788-8810-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8810-3) 68788-8810-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8810-6) 68788-8810-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8810-9)

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": "5d6941c7-ef0a-48d3-93dc-53bc2c9789de", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["5d6941c7-ef0a-48d3-93dc-53bc2c9789de"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8810-1)", "package_ndc": "68788-8810-1", "marketing_start_date": "20250120"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8810-3)", "package_ndc": "68788-8810-3", "marketing_start_date": "20250120"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8810-6)", "package_ndc": "68788-8810-6", "marketing_start_date": "20250120"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8810-9)", "package_ndc": "68788-8810-9", "marketing_start_date": "20250120"}], "brand_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "product_id": "68788-8810_5d6941c7-ef0a-48d3-93dc-53bc2c9789de", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8810", "generic_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOCETIRIZINE DIHYDROCHLORIDE", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205564", "marketing_category": "ANDA", "marketing_start_date": "20250120", "listing_expiration_date": "20261231"}