Fexofenadine Hcl Tablet, Film Coated
NDC Package 0904-7486-40

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

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, film coated delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-7486 and is authorized under FDA application ANDA204507.

Identification & Billing

NDC Package Code
0904-7486-40
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
0904-7486
11-Digit Billing Format
00904748640
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexofenadine Hcl
Non-Proprietary Name
Fexofenadine Hcl
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
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
Major Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
ANDA204507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-20-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0904-7486). Click a package code to view its specific billing and regulatory data.

0904-7486-02
30 TABLET, FILM COATED in 1 BOTTLE
0904-7486-60
100 TABLET, FILM COATED in 1 BOTTLE

* 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 0904-7486-40 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Fexofenadine Hcl, a human over the counter drug labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on August 20, 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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904748640. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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 (4-4-2)
0904-7486-40
11-Digit CMS (5-4-2)
00904-7486-40

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