Amoxicillin And Clavulanate Potassium Powder, For Suspension
NDC Package 0143-9982-75

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 Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder 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 Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9982 and is authorized under FDA application ANDA065191.

Identification & Billing

NDC Package Code
0143-9982-75
Package Description
75 mL in 1 BOTTLE
Product Code
0143-9982
11-Digit Billing Format
00143998275
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; Clavulanic Acid
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 Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder 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 Powder 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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065191
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2007
Listing Expiration
12-31-2027
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 (0143-9982). Click a package code to view its specific billing and regulatory data.

0143-9982-01
100 mL in 1 BOTTLE
0143-9982-50
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 0143-9982-75 identifies a specific commercial package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This powder, for suspension is formulated for oral use and contains amoxicillin; clavulanic acid 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 Hikma Pharmaceuticals Usa Inc. on December 01, 2007. The current certification is valid through December 31, 2027.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143998275. 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 (4-4-2)
0143-9982-75
11-Digit CMS (5-4-2)
00143-9982-75

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