levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Vensun Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 42543-712
Product ID 42543-712_e0dc4ba0-8ea1-47c3-8bed-427969ca5c15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203646
Listing Expiration 2026-12-31
Marketing Start 2014-10-27

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 42543712
Hyphenated Format 42543-712

Supplemental Identifiers

RxCUI
855172
UPC
0342543712904
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
  • 300 TABLET in 1 BOTTLE (42543-712-03)
  • 30 TABLET in 1 BOTTLE (42543-712-30)
  • 90 TABLET in 1 BOTTLE (42543-712-90)
source: ndc

Packages (3)

42543-712-03 300 TABLET in 1 BOTTLE (42543-712-03) 42543-712-30 30 TABLET in 1 BOTTLE (42543-712-30) 42543-712-90 90 TABLET in 1 BOTTLE (42543-712-90)

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": "e0dc4ba0-8ea1-47c3-8bed-427969ca5c15", "openfda": {"upc": ["0342543712904"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["7a2ca8aa-ba0b-45b4-bdb3-651879350130"], "manufacturer_name": ["Vensun Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE (42543-712-03)", "package_ndc": "42543-712-03", "marketing_start_date": "20141027"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42543-712-30)", "package_ndc": "42543-712-30", "marketing_start_date": "20141027"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42543-712-90)", "package_ndc": "42543-712-90", "marketing_start_date": "20141027"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "42543-712_e0dc4ba0-8ea1-47c3-8bed-427969ca5c15", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42543-712", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Vensun Pharmaceuticals, Inc.", "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": "20141027", "listing_expiration_date": "20261231"}