xyzal

Generic: levocetirizine dihydrochloride

Labeler: chattem, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xyzal
Generic Name levocetirizine dihydrochloride
Labeler chattem, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Chattem, Inc.

Identifiers & Regulatory

Product NDC 41167-5803
Product ID 41167-5803_87a83f00-5abf-437d-af13-394c22964050
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022064
Listing Expiration 2026-12-31
Marketing Start 2017-07-24

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 411675803
Hyphenated Format 41167-5803

Supplemental Identifiers

RxCUI
855168 855170 855172 855174
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 xyzal (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number NDA022064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)
source: ndc

Packages (1)

41167-5803-9 90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

Xyzal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "87a83f00-5abf-437d-af13-394c22964050", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855168", "855170", "855172", "855174"], "spl_set_id": ["1673f7ff-0c7c-4403-86cf-c05eb1475222"], "manufacturer_name": ["Chattem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)", "package_ndc": "41167-5803-9", "marketing_start_date": "20170724"}], "brand_name": "Xyzal", "product_id": "41167-5803_87a83f00-5abf-437d-af13-394c22964050", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41167-5803", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Chattem, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xyzal", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA022064", "marketing_category": "NDA", "marketing_start_date": "20170724", "listing_expiration_date": "20261231"}