Augmentin
NDC Package 43598-021-14

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.

Augmentin is amoxicillin/clavulanic acid is a combination penicillin-type antibiotic used to treat a wide variety of bacterial infections. Marketed by Dr. Reddy's Laboratories Inc, this product is identified by NDC 43598-021 and is authorized under FDA application NDA050720.

Identification & Billing

NDC Package Code
43598-021-14
Package Description
20 TABLET, FILM COATED in 1 BOTTLE
Product Code
43598-021
11-Digit Billing Format
43598002114
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: 562251 - amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin 250 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet

Clinical Specifications

Proprietary Name
Augmentin
Dosage Form
-
Usage Information
Amoxicillin/clavulanic acid is a combination penicillin-type antibiotic used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc
FDA Application #
NDA050720
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-02-1996
Listing Expiration
12-31-2018
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 (43598-021). Click a package code to view its specific billing and regulatory data.

43598-021-78
100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE

* 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 43598-021-14 identifies a specific commercial package of 20 tablet, film coated in 1 bottle of Augmentin, labeled by Dr. Reddy's Laboratories Inc. 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 Dr. Reddy's Laboratories Inc on October 02, 1996. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

Amoxicillin/clavulanic acid is a combination penicillin-type antibiotic used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Dr. Reddy's Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598002114. 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)
43598-021-14
11-Digit CMS (5-4-2)
43598-0021-14

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