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  5. NDC Package Code: 0781-1943-39 Amoxicillin And Clavulanate Potassium

NDC Package 0781-1943-39 Amoxicillin And Clavulanate Potassium

Tablet, Multilayer, Extended Release 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:
0781-1943-39
Package Description:
40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0781-1943
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name:
Amoxicillin And Clavulanate Potassium
Substance Name:
Amoxicillin; Amoxicillin Sodium; Clavulanate Potassium
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium extended release tablets and other antibacterial drugs, amoxicillin and clavulanate potassium extended release tablets 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 extended release tablets are indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase–producing pathogens (i.e., H.influenzae, M.catarrhalis, H.parainfluenzae, K.pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). Amoxicillin and clavulanate potassium extended release tablets are not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/ml [see Clinical Studies (14)].In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when amoxicillin and clavulanate potassium extended release tablets are prescribed.Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin- susceptible strain of S. pneumoniae plus a beta-lactamase–producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.
11-Digit NDC Billing Format:
00781194339
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
40 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 617995 - amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral Tablet
  • RxCUI: 617995 - 12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet
  • RxCUI: 617995 - amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMOXICILLIN 562.5 mg/1
  • AMOXICILLIN SODIUM 437.5 mg/1
  • CLAVULANATE POTASSIUM 62.5 mg/1
    • Pharmacologic Class(es):
  • Penicillin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • 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:
    ANDA090227
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-21-2010
    Listing Expiration Date:
    12-31-2024
    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
    0781-1943-8228 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-1943-39?

    The NDC Packaged Code 0781-1943-39 is assigned to a package of 40 tablet, multilayer, extended release in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Sandoz Inc. The product's dosage form is tablet, multilayer, extended release and is administered via oral form.

    Is NDC 0781-1943 included in the NDC Directory?

    Yes, Amoxicillin And Clavulanate Potassium with product code 0781-1943 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on April 21, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0781-1943-39?

    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 40.

    What is the 11-digit format for NDC 0781-1943-39?

    The 11-digit format is 00781194339. 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
    4-4-20781-1943-395-4-200781-1943-39