NDC Package 54868-0286-0 Amoxicillin And Clavulanate Potassium

View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

54868-0286-0

Package Description:

20 TABLET, CHEWABLE in 1 BOTTLE

Product Code:

54868-0286

Proprietary Name:

Amoxicillin And Clavulanate Potassium

Usage Information:

Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and 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 and clavulanate potassium. (See Microbiology.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 amoxicillin and clavulanate potassium tablets (chewable) should be performed together with any indicated surgical procedures.

11-Digit NDC Billing Format:

54868028600

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

20 EA

NDC to RxNorm Crosswalk:

RxCUI: 617316 - amoxicillin 400 MG / clavulanate potassium 57 MG Chewable Tablet

RxCUI: 617316 - amoxicillin 400 MG / clavulanate 57 MG Chewable Tablet

RxCUI: 617316 - amoxicillin 400 MG / clavulanate (as clavulanate potassium) 57 MG Chewable Tablet

Labeler Name:

Physicians Total Care, Inc.

Sample Package:

Start Marketing Date:

08-13-2007

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

54868 - Physicians Total Care, Inc.
- 54868-0286 - Amoxicillin And Clavulanate Potassium
  - 54868-0286-0 - 20 TABLET, CHEWABLE in 1 BOTTLE

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 54868-0286-0?

The NDC Packaged Code 54868-0286-0 is assigned to a package of 20 tablet, chewable in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package.

Is NDC 54868-0286 included in the NDC Directory?

No, Amoxicillin And Clavulanate Potassium with product code 54868-0286 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on August 13, 2007 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 54868-0286-0?

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 20.

What is the 11-digit format for NDC 54868-0286-0?

The 11-digit format is 54868028600. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	54868-0286-0	5-4-2	54868-0286-00

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