NDC Package 61919-019-20 Amoxicillin And Clavulanate Potassium

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

61919-019-20

Package Description:

20 TABLET, FILM COATED in 1 BOTTLE

Product Code:

61919-019

Proprietary Name:

Amoxicillin And Clavulanate Potassium

Usage Information:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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 for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:1.1 Infections of the Ear, Nose, and Throatdue to Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.1.2 Infections of the Genitourinary Tractdue to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.1.3 Infections of the Skin and Skin Structuredue to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.1.4 Infections of the Lower Respiratory Tractdue to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)due to Neisseria gonorrhoeae.Because of high rates of amoxicillin resistance, amoxicillin for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and LansoprazoleAmoxicillin for oral suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1.7 Dual Therapy for H. pylori with LansoprazoleAmoxicillin for oral suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

11-Digit NDC Billing Format:

61919001920

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

20 EA

NDC to RxNorm Crosswalk:

RxCUI: 308189 - amoxicillin 400 MG in 5 mL Oral Suspension
RxCUI: 308189 - amoxicillin 80 MG/ML Oral Suspension
RxCUI: 308189 - amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension
RxCUI: 617296 - amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet
RxCUI: 617296 - amoxicillin 500 MG / clavulanate 125 MG Oral Tablet

Labeler Name:

Direct Rx

Sample Package:

FDA Application Number:

ANDA065117

Marketing Category:

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

Start Marketing Date:

01-21-2021

End Marketing Date:

12-31-2023

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

61919 - Direct Rx
- 61919-019 - Amoxicillin And Clavulanate Potassium
  - 61919-019-20 - 20 TABLET, FILM COATED 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.

Frequently Asked Questions

What is NDC 61919-019-20?

The NDC Packaged Code 61919-019-20 is assigned to a package of 20 tablet, film coated in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Direct Rx. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package.

Is NDC 61919-019 included in the NDC Directory?

No, Amoxicillin And Clavulanate Potassium with product code 61919-019 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Direct Rx on January 21, 2021 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61919-019-20?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 20.

What is the 11-digit format for NDC 61919-019-20?

The 11-digit format is 61919001920. 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	61919-019-20	5-4-2	61919-0019-20

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