Fexofenadine Hydrochloride Tablet, Film Coated
NDC Package 73629-008-03

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

Package Information

Fexofenadine Hydrochloride tablets is temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, water eyessneezingitching of the nose or throat. This formulation utilizes a tablet, film coated delivery system. Marketed by Amz789 Llc, this product is identified by NDC 73629-008 and is authorized under FDA application ANDA211075.

Identification & Billing

NDC Package Code
73629-008-03
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
73629-008
11-Digit Billing Format
73629000803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexofenadine Hydrochloride
Non-Proprietary Name
Fexofenadine Hydrochloride
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 180 mg/1
Pharmacologic Class
Usage Information
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, water eyessneezingitching of the nose or throat

Regulatory & Marketing

Labeler Name
Amz789 Llc
Product Type
Human Otc Drug
FDA Application #
ANDA211075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-27-2024
Listing Expiration
12-31-2027
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 73629-008-03 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Fexofenadine Hydrochloride, a human over the counter drug labeled by Amz789 Llc. This tablet, film coated 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 Amz789 Llc on July 27, 2024. The current certification is valid through December 31, 2027.

How is this Amz789 Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73629000803. 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)
73629-008-03
11-Digit CMS (5-4-2)
73629-0008-03

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