Amoxicillin And Clavulanate Potassium
NDC Package 67046-1309-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Amoxicillin And Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:Lower Respiratory Tract Infections- caused by beta‑lactamase‑producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. Marketed by Coupler Llc, this product is identified by NDC 67046-1309 and is authorized under FDA application ANDA065063.

Identification & Billing

NDC Package Code
67046-1309-3
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-1309
11-Digit Billing Format
67046130903
RxNorm Crosswalk
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Dosage Form
-
Usage Information
Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:Lower Respiratory Tract Infections- caused by beta‑lactamase‑producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. Acute Bacterial Otitis Media- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis.Sinusitis- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. Skin and Skin Structure Infections- caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli,and Klebsiellaspecies. Urinary Tract Infections- caused by beta‑lactamase‑producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. Limitations of UseWhen susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat or prevent 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.

Regulatory & Marketing

Labeler Name
Coupler Llc
FDA Application #
ANDA065063
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-1309-3 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Amoxicillin And Clavulanate Potassium, labeled by Coupler Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Coupler Llc on November 11, 2024. The current certification is valid through December 31, 2025.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046130903. 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 (5-4-1)
67046-1309-3
11-Digit CMS (5-4-2)
67046-1309-03

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