Loratadine And Pseudoephedrine
NDC Package 54868-5656-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 is do not divide, crush, chew or dissolve the tabletadults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of age: ask a doctorconsumers with liver or kidney disease: ask a doctor. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5656 and is authorized under FDA application ANDA076557.

Identification & Billing

NDC Package Code
54868-5656-2
Package Description
3 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
54868-5656
11-Digit Billing Format
54868565602
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
Dosage Form
-
Usage Information
Do not divide, crush, chew or dissolve the tabletadults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of age: ask a doctorconsumers with liver or kidney disease: ask a doctor

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-27-2008
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5656). Click a package code to view its specific billing and regulatory data.

54868-5656-0
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
54868-5656-1
2 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 54868-5656-2 identifies a specific commercial package of 3 blister pack in 1 carton / 5 tablet, extended release in 1 blister pack of Loratadine And Pseudoephedrine, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on May 27, 2008. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868565602. 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 (5-4-1)
54868-5656-2
11-Digit CMS (5-4-2)
54868-5656-02

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