Amoxicillin And Clavulanate Potassium Powder, For Suspension
NDC Package 65862-533-75

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 powders is to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a powder, for suspension delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-533 and is authorized under FDA application ANDA201090.

Identification & Billing

NDC Package Code
65862-533-75
Package Description
75 mL in 1 BOTTLE
Product Code
65862-533
11-Digit Billing Format
65862053375
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
75 ML
RxNorm Crosswalk
  • RxCUI: 617423 - amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension
  • RxCUI: 617423 - amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension
  • RxCUI: 617423 - amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension
  • RxCUI: 617423 - amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension

Clinical Specifications

Proprietary Name
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name
Amoxicillin And Clavulanate Potassium
Substance Name
Amoxicillin; Clavulanate Potassium
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
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 for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 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 for oral suspension, 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*:

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA201090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-20-2011
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 (65862-533). Click a package code to view its specific billing and regulatory data.

65862-533-01
100 mL in 1 BOTTLE
65862-533-50
50 mL 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 65862-533-75 identifies a specific commercial package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Aurobindo Pharma Limited. This powder, for suspension is formulated for oral use and contains amoxicillin; 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 Aurobindo Pharma Limited on December 20, 2011. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862053375. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 75 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)
65862-533-75
11-Digit CMS (5-4-2)
65862-0533-75

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