Amoxicillin/clav Pot
NDC Package 61919-430-20

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amoxicillin/clav Pot is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets, USP and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Direct Rx, this product is identified by NDC 61919-430 and is authorized under FDA application ANDA203824.

Identification & Billing

NDC Package Code
61919-430-20
Package Description
20 TABLET in 1 BOTTLE
Product Code
61919-430
11-Digit Billing Format
61919043020
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
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/clav Pot
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets, USP and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets, 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 Tablets, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:1.1 Lower Respiratory Tract Infections -caused by beta-lactamase-producing isolates of Haemophilus influenzae and Moraxella catarrhalis.1.2 Acute Bacterial Otitis Media -caused by beta-lactamase-producing isolates of H. influenza and M. catarrhalis.1.3 Sinusitis -caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis.1.4 Skin and Skin Structure Infections-caused by beta-lactamase-producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.1.5 Urinary Tract Infections -caused by beta-lactamase-producing isolates of E. coli, Klebsiella species, and Enterobacter species.1.6 Limitations of Use -When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets, USP should not be used.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA203824
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2018
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61919-430). Click a package code to view its specific billing and regulatory data.

61919-430-14
14 TABLET 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 61919-430-20 identifies a specific commercial package of 20 tablet in 1 bottle of Amoxicillin/clav Pot, labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package. 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 Direct Rx on October 31, 2018. The current certification is valid through December 31, 2024.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919043020. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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 (5-3-2)
61919-430-20
11-Digit CMS (5-4-2)
61919-0430-20

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