Fexofenadine Hcl Tablet
NDC Package 51316-768-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fexofenadine Hcl tablets is fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. This formulation utilizes a tablet delivery system. Marketed by Cvs, this product is identified by NDC 51316-768 and is authorized under FDA application ANDA211075.

Identification & Billing

NDC Package Code
51316-768-06
Package Description
60 TABLET in 1 BOTTLE
Product Code
51316-768
11-Digit Billing Format
51316076806
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexofenadine Hcl
Non-Proprietary Name
Fexofenadine Hcl
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 180 mg/1
Pharmacologic Class
Usage Information
Fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.

Regulatory & Marketing

Labeler Name
Cvs
Product Type
Human Otc Drug
FDA Application #
ANDA211075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 51316-768-06 identifies a specific commercial package of 60 tablet in 1 bottle of Fexofenadine Hcl, a human over the counter drug labeled by Cvs. This tablet is formulated for oral use and contains fexofenadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cvs on January 01, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.

How is this Cvs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316076806. 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)
51316-768-06
11-Digit CMS (5-4-2)
51316-0768-06

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