Guardian Loratadine
NDC Package 53041-285-21

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.

Guardian Loratadine is  adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours  children under 6 years of age ask a doctor consumers with liver or kidney disease  ask a doctor. Marketed by Guardian Drug Company, this product is identified by NDC 53041-285 and is authorized under FDA application ANDA207569.

Identification & Billing

NDC Package Code
53041-285-21
Package Description
1000 TABLET in 1 BOTTLE
Product Code
53041-285
11-Digit Billing Format
53041028521
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Guardian Loratadine
Dosage Form
-
Usage Information
 adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours  children under 6 years of age ask a doctor consumers with liver or kidney disease  ask a doctor

Regulatory & Marketing

Labeler Name
Guardian Drug Company
FDA Application #
ANDA207569
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2019
Listing Expiration
12-31-2021
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 53041-285-21 identifies a specific commercial package of 1000 tablet in 1 bottle of Guardian Loratadine, labeled by Guardian Drug Company. 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 Guardian Drug Company on July 22, 2019. The current certification is valid through December 31, 2021.

How is this Guardian Drug Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53041028521. 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)
53041-285-21
11-Digit CMS (5-4-2)
53041-0285-21

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