Amoxicillin And Clavulanate Potassium Powder, For Suspension
NDC Package 85534-0080-0

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 amoxicillin and clavulanate potassium for oral suspension 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. This formulation utilizes a powder, for suspension delivery system. Marketed by Hawaii Repack, Inc., this product is identified by NDC 85534-0080 and is authorized under FDA application ANDA201090.

Identification & Billing

NDC Package Code
85534-0080-0
Package Description
50 mL in 1 BOTTLE
Product Code
85534-0080
11-Digit Billing Format
85534008000

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
Amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension should not be used.UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension  and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension  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
Hawaii Repack, Inc.
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
12-31-2027
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 (85534-0080). Click a package code to view its specific billing and regulatory data.

85534-0080-1
75 mL in 1 BOTTLE
85534-0080-2
100 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 85534-0080-0 identifies a specific commercial package of 50 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Hawaii Repack, Inc.. 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 Hawaii Repack, Inc. on December 20, 2011. The current certification is valid through December 31, 2027.

How is this Hawaii Repack, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85534008000. 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)
85534-0080-0
11-Digit CMS (5-4-2)
85534-0080-00

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