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  5. NDC Package Code: 43598-220-28 Amoxicillin And Clavulanate Potassium Extended Release

NDC Package 43598-220-28 Amoxicillin And Clavulanate Potassium Extended Release

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43598-220-28
Package Description:
28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
43598-220
Proprietary Name:
Amoxicillin And Clavulanate Potassium Extended Release
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Extended Release Tablets is indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase–producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). Amoxicillin and Clavulanate Potassium Extended Release Tablet is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/ml [see Clinical Studies (14)].In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablet is prescribed.Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a β-lactamase–producing pathogen can be treated with another amoxicillin/clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.
11-Digit NDC Billing Format:
43598022028
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
28 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 617995 - amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral Tablet
  • RxCUI: 617995 - 12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet
  • RxCUI: 617995 - amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet
    • Labeler Name:
    Dr. Reddy's Laboratories Inc
    Sample Package:
    No
    Start Marketing Date:
    09-11-2003
    Listing Expiration Date:
    12-31-2018
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43598-220-4040 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-220-28?

    The NDC Packaged Code 43598-220-28 is assigned to a package of 28 tablet, film coated, extended release in 1 bottle of Amoxicillin And Clavulanate Potassium Extended Release, labeled by Dr. Reddy's Laboratories Inc. The product's dosage form is and is administered via form.

    Is NDC 43598-220 included in the NDC Directory?

    No, Amoxicillin And Clavulanate Potassium Extended Release with product code 43598-220 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Dr. Reddy's Laboratories Inc on September 11, 2003 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43598-220-28?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 28.

    What is the 11-digit format for NDC 43598-220-28?

    The 11-digit format is 43598022028. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243598-220-285-4-243598-0220-28