Amoxicillin And Clavulanate Potassium
NDC Package 54868-5175-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Amoxicillin And Clavulanate Potassium is 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. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5175 and is authorized under FDA application ANDA065066.

Identification & Billing

NDC Package Code
54868-5175-0
Package Description
100 mL in 1 BOTTLE
Product Code
54868-5175
11-Digit Billing Format
54868517500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk
  • RxCUI: 617423 - amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension
  • RxCUI: 617423 - amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension
  • RxCUI: 617423 - amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension
  • RxCUI: 617423 - amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA065066
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-16-2005
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5175-0 identifies a specific commercial package of 100 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 Physicians Total Care, Inc. on March 16, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868517500. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. 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 (5-4-1)
54868-5175-0
11-Digit CMS (5-4-2)
54868-5175-00

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