NDC Package 73043-009-02 Amoxicillin And Clavulanate Potassium

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

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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:

73043-009-02

Package Description:

75 mL in 1 BOTTLE

Product Code:

73043-009

Proprietary Name:

Amoxicillin And Clavulanate Potassium

Non-Proprietary Name:

Amoxicillin And Clavulanate Potassium

Substance Name:

Amoxicillin; Clavulanate Potassium

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 and other antibacterial drugs, Amoxicillin and clavulanate potassium 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.

11-Digit NDC Billing Format:

73043000902

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:

Devatis, Inc.

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):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA210416

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

11-01-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

73043 - Devatis, Inc.
- 73043-009 - Amoxicillin And Clavulanate Potassium
  - 73043-009-02 - 75 mL in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
73043-009-01	50 mL in 1 BOTTLE
73043-009-03	100 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 73043-009-02?

The NDC Packaged Code 73043-009-02 is assigned to a package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Devatis, Inc.. The product's dosage form is powder, for suspension and is administered via oral form.

Is NDC 73043-009 included in the NDC Directory?

Yes, Amoxicillin And Clavulanate Potassium with product code 73043-009 is active and included in the NDC Directory. The product was first marketed by Devatis, Inc. on November 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 73043-009-02?

The 11-digit format is 73043000902. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	73043-009-02	5-4-2	73043-0009-02

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