levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-204
Product ID 82804-204_fe13f6c0-610b-43b6-8693-e9923ba405d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090385
Listing Expiration 2026-12-31
Marketing Start 2011-02-25

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 82804204
Hyphenated Format 82804-204

Supplemental Identifiers

RxCUI
855172
UPC
0382804204304
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 ANDA090385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-204-30)
source: ndc

Packages (1)

82804-204-30 30 TABLET in 1 BOTTLE (82804-204-30)

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": "fe13f6c0-610b-43b6-8693-e9923ba405d5", "openfda": {"upc": ["0382804204304"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["fe13f6c0-610b-43b6-8693-e9923ba405d5"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-204-30)", "package_ndc": "82804-204-30", "marketing_start_date": "20250307"}], "brand_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "product_id": "82804-204_fe13f6c0-610b-43b6-8693-e9923ba405d5", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "82804-204", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOCETIRIZINE DIHYDROCHLORIDE", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090385", "marketing_category": "ANDA", "marketing_start_date": "20110225", "listing_expiration_date": "20261231"}