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  5. NDC Package Code: 0781-6139-57 Amoxicillin And Clavulanate Potassium

NDC Package 0781-6139-57 Amoxicillin And Clavulanate Potassium

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
0781-6139-57
Package Description:
75 mL in 1 BOTTLE, DISPENSING
Product Code:
0781-6139
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name:
Amoxicillin And Clavulanate Potassium
Substance Name:
Amoxicillin; 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 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 β-lactamase-producing strains), or M. catarrhalis(including β-lactamase-producing strains) characterized by the following risk factors: • antibiotic 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. pneumoniaealone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, USP is not indicated for the treatment of acute otitis media due to S. pneumoniaewith 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 β-lactamase-producing organisms listed above.
11-Digit NDC Billing Format:
00781613957
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
75 ML
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMOXICILLIN 600 mg/5mL
  • CLAVULANATE POTASSIUM 42.9 mg/5mL
    • Pharmacologic Class(es):
  • Penicillin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Penicillins - [CS]
  • beta Lactamase Inhibitor - [EPC] (Established Pharmacologic Class)
  • beta Lactamase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA065358
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-13-2007
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0781-6139-48200 mL in 1 BOTTLE, DISPENSING
    0781-6139-54125 mL in 1 BOTTLE, DISPENSING

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-6139-57?

    The NDC Packaged Code 0781-6139-57 is assigned to a package of 75 ml in 1 bottle, dispensing of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Sandoz Inc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0781-6139 included in the NDC Directory?

    Yes, Amoxicillin And Clavulanate Potassium with product code 0781-6139 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on August 13, 2007 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0781-6139-57?

    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 75.

    What is the 11-digit format for NDC 0781-6139-57?

    The 11-digit format is 00781613957. 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 4-4-2 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
    4-4-20781-6139-575-4-200781-6139-57