levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-200
Product ID 33342-200_af9c84cc-0f32-4489-a65b-aaa9d93e65e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205564
Listing Expiration 2026-12-31
Marketing Start 2016-01-11

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 33342200
Hyphenated Format 33342-200

Supplemental Identifiers

RxCUI
855172
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 ANDA205564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-200-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-200-10)
source: ndc

Packages (2)

33342-200-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-200-07) 33342-200-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-200-10)

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": "af9c84cc-0f32-4489-a65b-aaa9d93e65e5", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["8a3c06a5-4a9a-4205-8ae7-c58efeb73c58"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-200-07)", "package_ndc": "33342-200-07", "marketing_start_date": "20160111"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-200-10)", "package_ndc": "33342-200-10", "marketing_start_date": "20160111"}], "brand_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "product_id": "33342-200_af9c84cc-0f32-4489-a65b-aaa9d93e65e5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "33342-200", "generic_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "labeler_name": "Macleods Pharmaceuticals Limited", "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": "20160111", "listing_expiration_date": "20261231"}