NDC Package 51655-158-03 Amoxicillan And Clavulanate Potassium

View Billable Units, 11-Digit Format, RxNorm

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:
51655-158-03
Package Description:
3 TABLET, FILM COATED in 1 BOTTLE, DISPENSING
Product Code:
Proprietary Name:
Amoxicillan And Clavulanate Potassium
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP 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 tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:1.1 Lower Respiratory Tract Infectionscaused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.1.2 Acute Bacterial Otitis Mediacaused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.1.3 Sinusitiscaused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.1.4 Skin and Skin Structure Infectionscaused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.1.5 Urinary Tract Infectionscaused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.1.6 Limitations of UseWhen susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.Please view the manufacturer's complete drug information at the FDA site:http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ffb158a1-83ba-4100-9221-175aa986dc3e
11-Digit NDC Billing Format:
51655015803
NDC to RxNorm Crosswalk:
  • RxCUI: 617296 - amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 617296 - amoxicillin 500 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 617296 - amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
  • Labeler Name:
    Northwind Pharmaceuticals, Llc
    Sample Package:
    No
    Start Marketing Date:
    07-18-2014
    Listing Expiration Date:
    12-31-2019
    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 51655-158-03?

    The NDC Packaged Code 51655-158-03 is assigned to a package of 3 tablet, film coated in 1 bottle, dispensing of Amoxicillan And Clavulanate Potassium, labeled by Northwind Pharmaceuticals, Llc. The product's dosage form is and is administered via form.

    Is NDC 51655-158 included in the NDC Directory?

    No, Amoxicillan And Clavulanate Potassium with product code 51655-158 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Northwind Pharmaceuticals, Llc on July 18, 2014 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51655-158-03?

    The 11-digit format is 51655015803. 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
    5-3-251655-158-035-4-251655-0158-03