Amoxicillin And Clavulanate Potassium Tablet, Multilayer, Extended Release
NDC Package 0781-1943-39

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amoxicillin And Clavulanate Potassium tablets is 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. This formulation utilizes a tablet, multilayer, extended release delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-1943 and is authorized under FDA application ANDA090227.

Identification & Billing

NDC Package Code
0781-1943-39
Package Description
40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Code
0781-1943
11-Digit Billing Format
00781194339
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
40 EA
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

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name
Amoxicillin And Clavulanate Potassium
Substance Name
Amoxicillin; Amoxicillin Sodium; Clavulanate Potassium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA090227
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2010
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0781-1943). Click a package code to view its specific billing and regulatory data.

0781-1943-82
28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

* 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 0781-1943-39 identifies a specific commercial package of 40 tablet, multilayer, extended release in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Sandoz Inc. This tablet, multilayer, extended release is formulated for oral use and contains amoxicillin; amoxicillin sodium; clavulanate potassium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sandoz Inc on April 21, 2010. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781194339. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 40 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 (4-4-2)
0781-1943-39
11-Digit CMS (5-4-2)
00781-1943-39

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