Allery Relief 24hr Tablet, Film Coated
NDC Package 69168-451-80

11-digit billing NDC: 69168045180
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Allery Relief 24hr tablets is adults 65 years of age and older                               ask a doctoradults and children 12 to 64 years of agetake 1 tablet (5 mg) once daily in the eveningdo not take more than 1 tablet (5 mg) in 24 hours½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 6 to 11 years of agetake ½ tablet (2.5 mg) once daily in the eveningdo not take more than ½ tablet (2.5 mg) in 24 hourschildren under 6 years of agedo not useconsumers with kidney diseasedo not use. This formulation utilizes a tablet, film coated delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-451 and is authorized under FDA application ANDA213513.

Identification & Billing

NDC Package Code
69168-451-80
Package Description
180 TABLET, FILM COATED in 1 BOTTLE
Product Code
69168-451
11-Digit Billing Format
69168045180
RxNorm Crosswalk
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet

Clinical Specifications

Proprietary Name
Allery Relief 24hr
Non-Proprietary Name
Allery Relief 24hr
Substance Name
Levocetirizine Dihydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
Adults 65 years of age and older                               ask a doctoradults and children 12 to 64 years of agetake 1 tablet (5 mg) once daily in the eveningdo not take more than 1 tablet (5 mg) in 24 hours½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 6 to 11 years of agetake ½ tablet (2.5 mg) once daily in the eveningdo not take more than ½ tablet (2.5 mg) in 24 hourschildren under 6 years of agedo not useconsumers with kidney diseasedo not use

Regulatory & Marketing

Labeler Name
Allegiant Health
Product Type
Human Otc Drug
FDA Application #
ANDA213513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-02-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69168-451). Click a package code to view its specific billing and regulatory data.

69168-451-06
120 TABLET, FILM COATED in 1 BOTTLE
69168-451-60
60 TABLET, FILM COATED in 1 BOTTLE

* 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 69168-451-80 identifies a specific commercial package of 180 tablet, film coated in 1 bottle of Allery Relief 24hr, a human over the counter drug labeled by Allegiant Health. This tablet, film coated is formulated for oral use and contains levocetirizine dihydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Allegiant Health on April 02, 2024. The current certification is valid through December 31, 2026.

How is this Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168045180. 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 (5-3-2)
69168-451-80
11-Digit CMS (5-4-2)
69168-0451-80

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