Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 46122-694-65

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

Package Information

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride tablets is do not divide, crush, chew or dissolve the tablet; swallow tablet wholeadults and children 12 years of age and overtake 1 tablet with a glass of water every 12 hours on an empty stomach; 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. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Amerisource Bergen, this product is identified by NDC 46122-694 and is authorized under FDA application ANDA090818.

Identification & Billing

NDC Package Code
46122-694-65
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
46122-694
11-Digit Billing Format
46122069465
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk
  • RxCUI: 997406 - fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 997406 - 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 997406 - fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Non-Proprietary Name
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Substance Name
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not divide, crush, chew or dissolve the tablet; swallow tablet wholeadults and children 12 years of age and overtake 1 tablet with a glass of water every 12 hours on an empty stomach; 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
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
ANDA090818
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2018
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 46122-694-65 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack of Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Amerisource Bergen. This tablet, film coated, extended release is formulated for oral use and contains fexofenadine hydrochloride; pseudoephedrine 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 March 01, 2018. 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: 46122069465. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
46122-694-65
11-Digit CMS (5-4-2)
46122-0694-65

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