levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride .5 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-917
Product ID 62135-917_0782ae1c-d903-d465-e063-6294a90a6676
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204599
Listing Expiration 2026-12-31
Marketing Start 2017-05-15

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 62135917
Hyphenated Format 62135-917

Supplemental Identifiers

RxCUI
855168
UPC
0362135917388
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 ANDA204599 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 148 mL in 1 BOTTLE (62135-917-38)
source: ndc

Packages (1)

62135-917-38 148 mL in 1 BOTTLE (62135-917-38)

Ingredients (1)

levocetirizine dihydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Levocetirizine Dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0782ae1c-d903-d465-e063-6294a90a6676", "openfda": {"upc": ["0362135917388"], "unii": ["SOD6A38AGA"], "rxcui": ["855168"], "spl_set_id": ["b56652ad-2cf8-4ed0-bb66-0e832772c792"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "148 mL in 1 BOTTLE (62135-917-38)", "package_ndc": "62135-917-38", "marketing_start_date": "20220830"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "62135-917_0782ae1c-d903-d465-e063-6294a90a6676", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62135-917", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA204599", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}