Levocetirizine Dihydrochloride
NDC Package 71309-112-18

11-digit billing NDC: 71309011218
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.

Levocetirizine Dihydrochloride is                 adults 65 years of age and older     ask a doctor   adults and children 12 to 64 years of age     take 1 tablet (5 mg) once daily in the evening   do not take more than 1 tablet (5 mg) in 24 hours  ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms   children 6 to 11 years of age     take ½ tablet (2.5 mg) once daily in the evening  do not take more than ½ tablet (2.5 mg) in 24 hours   children under 6 years of age     do not use   consumers with kidney disease     do not use    . Marketed by Safrel Pharmaceuticals Llc, this product is identified by NDC 71309-112 and is authorized under FDA application ANDA213513.

Identification & Billing

NDC Package Code
71309-112-18
Package Description
180 TABLET, FILM COATED in 1 BOTTLE
Product Code
71309-112
11-Digit Billing Format
71309011218
RxNorm Crosswalk
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet

Clinical Specifications

Proprietary Name
Levocetirizine Dihydrochloride
Dosage Form
-
Usage Information
                adults 65 years of age and older     ask a doctor   adults and children 12 to 64 years of age     take 1 tablet (5 mg) once daily in the evening   do not take more than 1 tablet (5 mg) in 24 hours  ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms   children 6 to 11 years of age     take ½ tablet (2.5 mg) once daily in the evening  do not take more than ½ tablet (2.5 mg) in 24 hours   children under 6 years of age     do not use   consumers with kidney disease     do not use    

Regulatory & Marketing

Labeler Name
Safrel Pharmaceuticals Llc
FDA Application #
ANDA213513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2022
Listing Expiration
12-31-2025
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 71309-112-18 identifies a specific commercial package of 180 tablet, film coated in 1 bottle of Levocetirizine Dihydrochloride, 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 October 28, 2022. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71309011218. 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)
71309-112-18
11-Digit CMS (5-4-2)
71309-0112-18

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