Loratadine And Pseudoephedrine Sulfate
NDC Package 37012-724-69

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.

Loratadine And Pseudoephedrine Sulfate is do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor. Marketed by Shopko Stores Operating Co., Llc, this product is identified by NDC 37012-724 and is authorized under FDA application ANDA076557.

Identification & Billing

NDC Package Code
37012-724-69
Package Description
10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
37012-724
11-Digit Billing Format
37012072469
RxNorm Crosswalk
  • RxCUI: 1117562 - pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1117562 - 24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet
  • RxCUI: 1117562 - loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Loratadine And Pseudoephedrine Sulfate
Dosage Form
-
Usage Information
Do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Regulatory & Marketing

Labeler Name
Shopko Stores Operating Co., Llc
FDA Application #
ANDA076557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-2004
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 37012-724-69 identifies a specific commercial package of 10 tablet, film coated, extended release in 1 blister pack of Loratadine And Pseudoephedrine Sulfate, labeled by Shopko Stores Operating Co., 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 Shopko Stores Operating Co., Llc on November 17, 2004. The current certification is valid through December 31, 2019.

How is this Shopko Stores Operating Co., Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 37012072469. 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)
37012-724-69
11-Digit CMS (5-4-2)
37012-0724-69

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