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 63187-663
Product ID 63187-663_9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7f
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 63187663
Hyphenated Format 63187-663

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 ANDA203646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-663-30)
  • 60 TABLET in 1 BOTTLE (63187-663-60)
  • 90 TABLET in 1 BOTTLE (63187-663-90)
source: ndc

Packages (3)

63187-663-30 30 TABLET in 1 BOTTLE (63187-663-30) 63187-663-60 60 TABLET in 1 BOTTLE (63187-663-60) 63187-663-90 90 TABLET in 1 BOTTLE (63187-663-90)

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": "9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7f", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["b84ccb27-9c52-43b9-9a46-8f52a571045e"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-663-30)", "package_ndc": "63187-663-30", "marketing_start_date": "20160301"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-663-60)", "package_ndc": "63187-663-60", "marketing_start_date": "20160301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-663-90)", "package_ndc": "63187-663-90", "marketing_start_date": "20160301"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "63187-663_9dd81e5d-5ec6-41c5-b76a-c0c3488c6d7f", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63187-663", "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": "ANDA203646", "marketing_category": "ANDA", "marketing_start_date": "20141027", "listing_expiration_date": "20261231"}