Allegra D-12 Hour
NDC Package 54868-4258-3

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.

Allegra D-12 Hour is aLLEGRA-D 12 HOUR Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4258 and is authorized under FDA application NDA020786.

Identification & Billing

NDC Package Code
54868-4258-3
Package Description
10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
54868-4258
11-Digit Billing Format
54868425803
RxNorm Crosswalk
  • RxCUI: 997406 - fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 997406 - 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 997406 - fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 997512 - Allegra-D 60 MG /120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 997512 - 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Allegra-D]

Clinical Specifications

Proprietary Name
Allegra D-12 Hour
Dosage Form
-
Usage Information
ALLEGRA-D 12 HOUR Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.ALLEGRA-D 12 HOUR should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020786
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-18-2000
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 (54868-4258). Click a package code to view its specific billing and regulatory data.

54868-4258-0
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
54868-4258-1
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
54868-4258-2
20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 54868-4258-3 identifies a specific commercial package of 10 tablet, extended release in 1 bottle, plastic of Allegra D-12 Hour, 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 September 18, 2000. 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: 54868425803. 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)
54868-4258-3
11-Digit CMS (5-4-2)
54868-4258-03

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