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  5. NDC Package Code: 45865-928-01 Amoxicillin And Clavulanate Potassium

NDC Package 45865-928-01 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:
45865-928-01
Package Description:
75 mL in 1 BOTTLE
Product Code:
45865-928
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors: antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: - age 2 years or younger - daycare attendance [see CLINICAL PHARMACOLOGY, Microbiology ( 12.4)] NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the beta-lactamase–producing organisms listed above.
11-Digit NDC Billing Format:
45865092801
NDC to RxNorm Crosswalk:
  • RxCUI: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension
  • RxCUI: 617993 - amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension
  • RxCUI: 617993 - amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension
  • RxCUI: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension
    • Labeler Name:
    Medsource Pharmaceuticals
    Sample Package:
    No
    Start Marketing Date:
    09-23-2004
    Listing Expiration Date:
    12-31-2022
    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 45865-928-01?

    The NDC Packaged Code 45865-928-01 is assigned to a package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Medsource Pharmaceuticals. The product's dosage form is and is administered via form.

    Is NDC 45865-928 included in the NDC Directory?

    No, Amoxicillin And Clavulanate Potassium with product code 45865-928 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Medsource Pharmaceuticals on September 23, 2004 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 45865-928-01?

    The 11-digit format is 45865092801. 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
    5-3-245865-928-015-4-245865-0928-01