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  5. NDC Package Code: 53808-0740-1 Amoxicillin And Clavulanate Potassium

NDC Package 53808-0740-1 Amoxicillin And Clavulanate Potassium

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
53808-0740-1
Package Description:
30 DOSE PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 DOSE PACK
Product Code:
53808-0740
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Usage Information:
Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp.Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp.While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See Microbiology.)To reduce the development of drug-resistant bacteria and maintain the effectivness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent 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.Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.
11-Digit NDC Billing Format:
53808074001
NDC to RxNorm Crosswalk:
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
    • Labeler Name:
    State Of Florida Doh Central Pharmacy
    Sample Package:
    No
    Start Marketing Date:
    07-01-2009
    Listing Expiration Date:
    12-31-2017
    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.

    Frequently Asked Questions

    What is NDC 53808-0740-1?

    The NDC Packaged Code 53808-0740-1 is assigned to a package of 30 dose pack in 1 carton / 1 tablet, film coated in 1 dose pack of Amoxicillin And Clavulanate Potassium, labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form.

    Is NDC 53808-0740 included in the NDC Directory?

    No, Amoxicillin And Clavulanate Potassium with product code 53808-0740 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by State Of Florida Doh Central Pharmacy on July 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53808-0740-1?

    The 11-digit format is 53808074001. 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 5-4-1 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
    5-4-153808-0740-15-4-253808-0740-01