Amoxicillin And Clavulanate Potassium Suspension
NDC Package 69097-098-08

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 suspension 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 influenzae and Moraxella catarrhalis.Acute Bacterial Otitis Media - caused by beta-lactamase–producing isolates of H. This formulation utilizes a suspension delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-098 and is authorized under FDA application ANDA065431.

Identification & Billing

NDC Package Code
69097-098-08
Package Description
150 mL in 1 BOTTLE
Product Code
69097-098
11-Digit Billing Format
69097009808
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
150 ML
RxNorm Crosswalk
  • RxCUI: 617322 - amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension
  • RxCUI: 617322 - amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension
  • RxCUI: 617322 - amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension
  • RxCUI: 617322 - amoxicillin 250 MG / clavulanic acid 62.5 MG per 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
Suspension - A liquid1 dosage form that contains solid particles dispersed in a 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 influenzae and Moraxella catarrhalis.Acute Bacterial Otitis Media - caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.Sinusitis - caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.Skin and Skin Structure Infections - caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.Urinary Tract Infections - caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065431
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2024
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 (69097-098). Click a package code to view its specific billing and regulatory data.

69097-098-43
75 mL in 1 BOTTLE
69097-098-44
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 69097-098-08 identifies a specific commercial package of 150 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Cipla Usa Inc.. This 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 Cipla Usa Inc. on October 28, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097009808. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 150 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)
69097-098-08
11-Digit CMS (5-4-2)
69097-0098-08

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