Cetirizine Hydrochloride Tablet, Coated
NDC Package 80513-731-12

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

Package Information

Cetirizine Hydrochloride tablets is adults and children 6 years and overOne 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. This formulation utilizes a tablet, coated delivery system. Marketed by Advanced Rx Llc, this product is identified by NDC 80513-731 and is authorized under FDA application ANDA209274.

Identification & Billing

NDC Package Code
80513-731-12
Package Description
120 TABLET, COATED in 1 BOTTLE
Product Code
80513-731
11-Digit Billing Format
80513073112
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Adults and children 6 years and overOne 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.adults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Advanced Rx Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2025
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 (80513-731). Click a package code to view its specific billing and regulatory data.

80513-731-05
500 TABLET, 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 80513-731-12 identifies a specific commercial package of 120 tablet, coated in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Advanced Rx Llc. This tablet, coated is formulated for oral use and contains cetirizine hydrochloride 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 Advanced Rx Llc on May 01, 2025. The current certification is valid through December 31, 2026.

How is this Advanced Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80513073112. 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)
80513-731-12
11-Digit CMS (5-4-2)
80513-0731-12

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