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  5. NDC Package Code: 21695-546-00 Amoxicillin And Clavulanate Potassium

NDC Package 21695-546-00 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:
21695-546-00
Package Description:
100 mL in 1 BOTTLE
Product Code:
21695-546
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Usage Information:
Amoxicillin and clavulanate potassium for oral suspension and chewable tablets are 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-lactamaseproducing 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-lactamaseproducing 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 and clavulanate potassium for oral suspension and chewable tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin and clavulanate potassium for oral suspension and chewable tablets treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and clavulanate potassium for oral suspension and chewable tablets 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 and clavulanate potassium for oral suspension and chewable tablets. (See Microbiology.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension and chewable tablets 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 and clavulanate potassium for oral suspension and chewable tablets, should be performed together with any indicated surgical procedures.
11-Digit NDC Billing Format:
21695054600
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
100 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension
  • RxCUI: 617430 - amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension
  • RxCUI: 617430 - amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension
    • Labeler Name:
    Rebel Distributors Corp.
    Sample Package:
    No
    Start Marketing Date:
    06-05-2002
    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 21695-546-00?

    The NDC Packaged Code 21695-546-00 is assigned to a package of 100 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Rebel Distributors Corp.. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

    Is NDC 21695-546 included in the NDC Directory?

    No, Amoxicillin And Clavulanate Potassium with product code 21695-546 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rebel Distributors Corp. on June 05, 2002 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 NDC billing unit for package 21695-546-00?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 21695-546-00?

    The 11-digit format is 21695054600. 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
    5-3-221695-546-005-4-221695-0546-00