Amoxicillin/clav Pot Oral Susp Powder, For Suspension
NDC Package 72189-367-32

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amoxicillin/clav Pot Oral Susp 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 Direct_rx, this product is identified by NDC 72189-367 and is authorized under FDA application ANDA201090.

Identification & Billing

NDC Package Code
72189-367-32
Package Description
5 mL in 1 BOTTLE
Product Code
72189-367
11-Digit Billing Format
72189036732
RxNorm Crosswalk
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension
  • RxCUI: 617430 - amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension
  • RxCUI: 617430 - amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Amoxicillin/clav Pot Oral Susp
Non-Proprietary Name
Amoxicillin/clav Pot Oral Susp
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*: 1.1 Lower Respiratory Tract Infectionscaused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.1.2 Acute Bacterial Otitis Mediacaused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.1.3 Sinusitiscaused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.1.4 Skin and Skin Structure Infectionscaused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.1.5 Urinary Tract Infectionscaused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.1.6 Limitations of UseWhen susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension, USP should not be used.

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA201090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-08-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-367-32 identifies a specific commercial package of 5 ml in 1 bottle of Amoxicillin/clav Pot Oral Susp, a human prescription drug labeled by Direct_rx. 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 Direct_rx on August 08, 2022. The current certification is valid through December 31, 2026.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189036732. 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)
72189-367-32
11-Digit CMS (5-4-2)
72189-0367-32

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