Fexofenadine Hcl And Pseudoephedrine Hcl Tablet, Extended Release
NDC Package 43598-892-00

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Fexofenadine Hcl And Pseudoephedrine Hcl tablets is do not divide, crush, chew or dissolve the tablet; swallow tablet wholeadults and children 12 years of age and over   take 1 tablet with a glass of water every 24 hours on an empty stomach; 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, extended release delivery system. Marketed by Dr.reddy's Laboratories Inc, this product is identified by NDC 43598-892 and is authorized under FDA application ANDA079043.

Identification & Billing

NDC Package Code
43598-892-00
Package Description
50000 TABLET, EXTENDED RELEASE in 1 DRUM
Product Code
43598-892
11-Digit Billing Format
43598089200
RxNorm Crosswalk
  • RxCUI: 997415 - fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet
  • RxCUI: 997415 - 24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet
  • RxCUI: 997415 - fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet

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.
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 over   take 1 tablet with a glass of water every 24 hours on an empty stomach; 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
Dr.reddy's Laboratories Inc
Product Type
Human Otc Drug
FDA Application #
ANDA079043
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2022
End Marketing Date
08-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43598-892). Click a package code to view its specific billing and regulatory data.

43598-892-07
1 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
43598-892-29
3 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
43598-892-35
2 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 43598-892-00 identifies a specific commercial package of 50000 tablet, extended release in 1 drum of Fexofenadine Hcl And Pseudoephedrine Hcl, a human over the counter drug labeled by Dr.reddy's Laboratories Inc. This tablet, 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 Dr.reddy's Laboratories Inc on May 17, 2022.

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: 43598089200. 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)
43598-892-00
11-Digit CMS (5-4-2)
43598-0892-00

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