NDC Package 53041-285-21 Guardian Loratadine

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53041-285-21
Package Description:
1000 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Guardian Loratadine
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
11-Digit NDC Billing Format:
53041028521
NDC to RxNorm Crosswalk:
  • RxCUI: 311372 - loratadine 10 MG 24HR Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG 24 HR Oral Tablet
  • Labeler Name:
    Guardian Drug Company
    Sample Package:
    No
    Start Marketing Date:
    07-22-2019
    Listing Expiration Date:
    12-31-2021
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 53041-285-21?

    The NDC Packaged Code 53041-285-21 is assigned to a package of 1000 tablet in 1 bottle of Guardian Loratadine, labeled by Guardian Drug Company. The product's dosage form is and is administered via form.

    Is NDC 53041-285 included in the NDC Directory?

    No, Guardian Loratadine with product code 53041-285 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Guardian Drug Company on July 22, 2019 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53041-285-21?

    The 11-digit format is 53041028521. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253041-285-215-4-253041-0285-21