levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-479
Product ID 43063-479_3ed97d6e-d710-dd18-e063-6294a90ac4ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090199
Listing Expiration 2026-12-31
Marketing Start 2011-09-06

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 43063479
Hyphenated Format 43063-479

Supplemental Identifiers

RxCUI
855172
UPC
0343063479308
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 ANDA090199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30)
source: ndc

Packages (1)

43063-479-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30)

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": "3ed97d6e-d710-dd18-e063-6294a90ac4ae", "openfda": {"upc": ["0343063479308"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["344ba2d6-4e17-4cef-bd7b-248fbb1af3b6"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30)", "package_ndc": "43063-479-30", "marketing_start_date": "20131030"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "43063-479_3ed97d6e-d710-dd18-e063-6294a90ac4ae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "43063-479", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090199", "marketing_category": "ANDA", "marketing_start_date": "20110906", "listing_expiration_date": "20261231"}