Childrens Xyzal Allergy
NDC Package 41167-3530-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Childrens Xyzal Allergy is use only with enclosed dosing cupadults 65 years of age and older■ ask a doctoradults and children 12-64 years of age■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age■ take 5 mL once daily in the evening■ do not take more than 5 mL in 24 hourschildren 2-5 years of age■ take 2.5 mL once daily in the evening■ do not take more than 2.5 mL in 24 hourschildren under 2 years of age■ do not useconsumers with kidney disease■ do not useNote: mL = milliliters. Marketed by Chattem, Inc., this product is identified by NDC 41167-3530 and is authorized under FDA application NDA209090.

Identification & Billing

NDC Package Code
41167-3530-1
Package Description
1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
Product Code
41167-3530
11-Digit Billing Format
41167353001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 855168 - levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution
  • RxCUI: 855168 - levocetirizine dihydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 855168 - levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution
  • RxCUI: 855170 - XYZAL 2.5 MG in 5 mL 24HR Oral Solution
  • RxCUI: 855170 - levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [Xyzal]

Clinical Specifications

Proprietary Name
Childrens Xyzal Allergy
Dosage Form
-
Usage Information
Use only with enclosed dosing cupadults 65 years of age and older■ ask a doctoradults and children 12-64 years of age■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age■ take 5 mL once daily in the evening■ do not take more than 5 mL in 24 hourschildren 2-5 years of age■ take 2.5 mL once daily in the evening■ do not take more than 2.5 mL in 24 hourschildren under 2 years of age■ do not useconsumers with kidney disease■ do not useNote: mL = milliliters

Regulatory & Marketing

Labeler Name
Chattem, Inc.
FDA Application #
NDA209090
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2023
End Marketing Date
11-01-2025
Listing Expiration
11-01-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 41167-3530-1 identifies a specific commercial package of 1 bottle in 1 carton / 148 ml in 1 bottle of Childrens Xyzal Allergy, labeled by Chattem, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Chattem, Inc. on February 01, 2023. The current certification is valid through November 01, 2025.

How is this Chattem, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41167353001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
41167-3530-1
11-Digit CMS (5-4-2)
41167-3530-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.