Cetirizine Hydrochloride
NDC Package 71309-005-03

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 inactivated by the FDA.

Cetirizine Hydrochloride 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. Marketed by Safrel Pharmaceuticals, Llc, this product is identified by NDC 71309-005 and is authorized under FDA application ANDA209274.

Identification & Billing

NDC Package Code
71309-005-03
Package Description
300 TABLET, COATED in 1 BOTTLE
Product Code
71309-005
11-Digit Billing Format
71309000503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Dosage Form
-
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
Safrel Pharmaceuticals, Llc
FDA Application #
ANDA209274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2018
Listing Expiration
12-31-2023
Exclude Flag
I
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 71309-005-03 identifies a specific commercial package of 300 tablet, coated in 1 bottle of Cetirizine Hydrochloride, labeled by Safrel Pharmaceuticals, Llc. 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 Safrel Pharmaceuticals, Llc on May 28, 2018. The current certification is valid through December 31, 2023.

How is this Safrel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71309000503. 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)
71309-005-03
11-Digit CMS (5-4-2)
71309-0005-03

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