Amoxicillin And Clavulanate Potassium
NDC Package 43598-221-78

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amoxicillin And Clavulanate Potassium is to reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Dr. Reddy's Laboratories Inc, this product is identified by NDC 43598-221 and is authorized under FDA application NDA050720.

Identification & Billing

NDC Package Code
43598-221-78
Package Description
100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE
Product Code
43598-221
11-Digit Billing Format
43598022178
RxNorm Crosswalk
  • RxCUI: 562251 - amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin 250 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Dosage Form
-
Usage Information
To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and Clavulanate Potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc
FDA Application #
NDA050720
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-02-1996
Listing Expiration
12-31-2018
Exclude Flag
I
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 (43598-221). Click a package code to view its specific billing and regulatory data.

43598-221-14
20 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 43598-221-78 identifies a specific commercial package of 100 tablet, film coated in 1 box, unit-dose of Amoxicillin And Clavulanate Potassium, labeled by Dr. Reddy's Laboratories Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Dr. Reddy's Laboratories Inc on October 02, 1996. The current certification is valid through December 31, 2018.

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: 43598022178. 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)
43598-221-78
11-Digit CMS (5-4-2)
43598-0221-78

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