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  5. NDC Package Code: 72189-367-32 Amoxicillin/clav Pot Oral Susp

NDC Package 72189-367-32 Amoxicillin/clav Pot Oral Susp

Powder, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
72189-367-32
Package Description:
5 mL in 1 BOTTLE
Product Code:
72189-367
Proprietary Name:
Amoxicillin/clav Pot Oral Susp
Non-Proprietary Name:
Amoxicillin/clav Pot Oral Susp
Substance Name:
Amoxicillin; Clavulanate Potassium
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.
11-Digit NDC Billing Format:
72189036732
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Direct_rx
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMOXICILLIN 400 mg/5mL
  • CLAVULANATE POTASSIUM 57 mg/5mL
    • Pharmacologic Class(es):
  • Penicillin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Penicillins - [CS]
  • beta Lactamase Inhibitor - [EPC] (Established Pharmacologic Class)
  • beta Lactamase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA201090
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-08-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 72189-367-32?

    The NDC Packaged Code 72189-367-32 is assigned to a package of 5 ml in 1 bottle of Amoxicillin/clav Pot Oral Susp, a human prescription drug labeled by Direct_rx. The product's dosage form is powder, for suspension and is administered via oral form.

    Is NDC 72189-367 included in the NDC Directory?

    Yes, Amoxicillin/clav Pot Oral Susp with product code 72189-367 is active and included in the NDC Directory. The product was first marketed by Direct_rx on August 08, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 72189-367-32?

    The 11-digit format is 72189036732. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-272189-367-325-4-272189-0367-32