Fexofenadine Hcl And Pseudoephedrine Hcl Tablet, Extended Release
NDC Package 43598-026-40

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fexofenadine Hcl And Pseudoephedrine Hcl tablets is a drug for further processing. This formulation utilizes a tablet, extended release delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-026.

Identification & Billing

NDC Package Code
43598-026-40
Package Description
35 TABLET, EXTENDED RELEASE in 1 CARTON
Product Code
43598-026
11-Digit Billing Format
43598002640

Clinical Specifications

Proprietary Name
Fexofenadine Hcl And Pseudoephedrine Hcl
Non-Proprietary Name
Fexofenadine Hcl And Pseudoephedrine Hcl
Substance Name
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-15-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 43598-026-40 identifies a specific commercial package of 35 tablet, extended release in 1 carton of Fexofenadine Hcl And Pseudoephedrine Hcl (UNFINISHED drug), drug for further processing labeled by Dr. Reddy's Laboratories Inc.. This tablet, extended release is formulated for 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 Dr. Reddy's Laboratories Inc. on May 15, 2023. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598002640. 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)
43598-026-40
11-Digit CMS (5-4-2)
43598-0026-40

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