Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 59651-033-99

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 Hydrochloride And Pseudoephedrine Hydrochloride tablets is a drug for further processing. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 59651-033.

Identification & Billing

NDC Package Code
59651-033-99
Package Description
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG
Product Code
59651-033
11-Digit Billing Format
59651003399

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.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
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
10-30-2017
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 59651-033-99 identifies a specific commercial package of 1000 tablet, film coated, extended release in 1 bag of Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride (UNFINISHED drug), drug for further processing labeled by Aurobindo Pharma Limited. This tablet, film coated, 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 Aurobindo Pharma Limited on October 30, 2017. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59651003399. 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)
59651-033-99
11-Digit CMS (5-4-2)
59651-0033-99

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