Loratadine
NDC Package 41520-513-24

11-digit billing NDC: 41520051324
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.

Loratadine is place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 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 American Sales Company, this product is identified by NDC 41520-513 and is authorized under FDA application ANDA077153.

Identification & Billing

NDC Package Code
41520-513-24
Package Description
24 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
41520-513
11-Digit Billing Format
41520051324
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loratadine
Dosage Form
-
Usage Information
Place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 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
American Sales Company
FDA Application #
ANDA077153
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2007
Listing Expiration
12-31-2019
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 41520-513-24 identifies a specific commercial package of 24 tablet, orally disintegrating in 1 blister pack of Loratadine, labeled by American Sales 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 American Sales Company on August 31, 2007. The current certification is valid through December 31, 2019.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520051324. 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)
41520-513-24
11-Digit CMS (5-4-2)
41520-0513-24

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