Avelox
NDC Package 54868-4367-3

11-digit billing NDC: 54868436703 · Billing unit: EA · 7 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Avelox is to reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4367 and is authorized under FDA application NDA021085.

Identification & Billing

NDC Package Code
54868-4367-3
Package Description
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
54868-4367
11-Digit Billing Format
54868436703
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Avelox
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX 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.AVELOX  Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use In Specific Populations (8.5)].Culture and Susceptibility TestingAppropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin [see Clinical Pharmacology (12.4)]. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021085
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-16-2009
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4367). Click a package code to view its specific billing and regulatory data.

54868-4367-0
5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4367-1
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4367-2
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4367-4
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4367-5
2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 54868-4367-3 identifies a specific commercial package of 7 tablet, film coated in 1 bottle, plastic of Avelox, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 7 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 Physicians Total Care, Inc. on July 16, 2009. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868436703. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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 (5-4-1)
54868-4367-3
11-Digit CMS (5-4-2)
54868-4367-03

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