Cefditoren Pivoxil
NDC Package 44009-802-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Cefditoren Pivoxil is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase producing strains).Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. Marketed by Pharma Romlev Inc., this product is identified by NDC 44009-802 and is authorized under FDA application NDA021222.

Identification & Billing

NDC Package Code
44009-802-28
Package Description
28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
44009-802
11-Digit Billing Format
44009080228
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefditoren Pivoxil
Dosage Form
-
Usage Information
Cefditoren Pivoxil is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase producing strains).Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: Cefditoren Pivoxil is effective in the eradication of Streptococcus pyogenes from the oropharynx. Cefditoren Pivoxil Tablets has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including ß-lactamase-producing strains) or Streptococcus pyogenes.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefditoren Pivoxil and other antibacterial drugs, Cefditoren Pivoxil 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.

Regulatory & Marketing

Labeler Name
Pharma Romlev Inc.
FDA Application #
NDA021222
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2010
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 (44009-802). Click a package code to view its specific billing and regulatory data.

44009-802-20
20 TABLET, FILM COATED in 1 BLISTER PACK

* 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 44009-802-28 identifies a specific commercial package of 28 tablet, film coated in 1 blister pack of Cefditoren Pivoxil, labeled by Pharma Romlev Inc.. 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 Pharma Romlev Inc. on January 01, 2010. The current certification is valid through December 31, 2017.

How is this Pharma Romlev Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44009080228. 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)
44009-802-28
11-Digit CMS (5-4-2)
44009-0802-28

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