Amoxil
NDC Package 61919-716-33

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amoxil is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin 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. Marketed by Direct_rx, this product is identified by NDC 61919-716 and is authorized under FDA application ANDA065322.

Identification & Billing

NDC Package Code
61919-716-33
Package Description
5 mL in 1 BOTTLE
Product Code
61919-716
11-Digit Billing Format
61919071633
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML

Clinical Specifications

Proprietary Name
Amoxil
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin 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 throat - due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. 1.2 Infections of the genitourinary tract - due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. 1.3 Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. 1.4 Infections of the lower respiratory tract - due 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 in males and females) - 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 lansoprazole: Amoxicillin 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 lansoprazole: Amoxicillin 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.

Regulatory & Marketing

Labeler Name
Direct_rx
FDA Application #
ANDA065322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2016
Listing Expiration
12-31-2024
Exclude Flag
I
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 61919-716-33 identifies a specific commercial package of 5 ml in 1 bottle of Amoxil, labeled by Direct_rx. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct_rx on March 04, 2016. The current certification is valid through December 31, 2024.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919071633. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 total billable units per package. 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)
61919-716-33
11-Digit CMS (5-4-2)
61919-0716-33

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