Fexofenadine Hydrochloride Tablet, Film Coated
NDC Package 46122-779-66

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 Hydrochloride tablets is adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Amerisource Bergen, this product is identified by NDC 46122-779 and is authorized under FDA application ANDA091567.

Identification & Billing

NDC Package Code
46122-779-66
Package Description
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
Product Code
46122-779
11-Digit Billing Format
46122077966
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
Adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet 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
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
ANDA091567
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2024
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 (46122-779). Click a package code to view its specific billing and regulatory data.

46122-779-58
3 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED in 1 BLISTER PACK
46122-779-61
1 BOTTLE in 1 CARTON / 30 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 46122-779-66 identifies a specific commercial package of 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle of Fexofenadine Hydrochloride, a human over the counter drug labeled by Amerisource Bergen. 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 Amerisource Bergen on May 14, 2024. The current certification is valid through December 31, 2026.

How is this Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122077966. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
46122-779-66
11-Digit CMS (5-4-2)
46122-0779-66

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