NDC Package 61919-637-20 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 inactivated by the FDA.

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:

61919-637-20

Package Description:

20 TABLET, FILM COATED in 1 BOTTLE

Product Code:

61919-637

Proprietary Name:

Amoxicillin And Clavulanate Potassium

Usage Information:

To 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 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 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 influenzaeand Moraxella catarrhalis.1.2 Acute Bacterial Otitis Mediacaused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis.1.3 Sinusitiscaused by beta‑lactamase–producing isolates of H. influenzaeand M. catarrhalis.1.4 Skin and Skin Structure Infectionscaused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, andKlebsiellaspecies.1.5 Urinary Tract Infectionscaused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, andEnterobacterspecies.1.6 Limitations of UseWhen susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.

11-Digit NDC Billing Format:

61919063720

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: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet

RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet

RxCUI: 562508 - amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet

Labeler Name:

Directrx

Sample Package:

Start Marketing Date:

11-25-2015

Listing Expiration Date:

12-31-2022

Exclude Flag:

Code Structure:

61919 - Directrx
- 61919-637 - Amoxicillin And Clavulanate Potassium
  - 61919-637-20 - 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 61919-637-20?

The NDC Packaged Code 61919-637-20 is assigned to a package of 20 tablet, film coated in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Directrx. 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 61919-637 included in the NDC Directory?

No, Amoxicillin And Clavulanate Potassium with product code 61919-637 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Directrx on November 25, 2015 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61919-637-20?

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 61919-637-20?

The 11-digit format is 61919063720. 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	61919-637-20	5-4-2	61919-0637-20

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