Fexofenadine Hydrochloride
NDC Package 43353-760-53

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.

Fexofenadine Hydrochloride is adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-760 and is authorized under FDA application ANDA077081.

Identification & Billing

NDC Package Code
43353-760-53
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
43353-760
11-Digit Billing Format
43353076053
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexofenadine Hydrochloride
Dosage Form
-
Usage Information
Adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA077081
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2014
Listing Expiration
12-31-2018
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 (43353-760). Click a package code to view its specific billing and regulatory data.

43353-760-60
90 TABLET, FILM COATED 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 43353-760-53 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Fexofenadine Hydrochloride, labeled by Aphena Pharma Solutions - Tennessee, 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 Aphena Pharma Solutions - Tennessee, Llc on March 20, 2014. The current certification is valid through December 31, 2018.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353076053. 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)
43353-760-53
11-Digit CMS (5-4-2)
43353-0760-53

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