Cephalexin
NDC Package 68289-009-01

11-digit billing NDC: 68289000901
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.

Cephalexin is for Oral Suspension USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Marketed by Jazeera Pharmaceutical, this product is identified by NDC 68289-009 and is authorized under FDA application ANDA065444.

Identification & Billing

NDC Package Code
68289-009-01
Package Description
100 mL in 1 BOTTLE
Product Code
68289-009
11-Digit Billing Format
68289000901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin Usp
Dosage Form
-
Usage Information
Cephalexin for Oral Suspension USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin for Oral Suspension USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin for Oral Suspension USP in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae Note— Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for Oral Suspension USP and other antibacterial drugs, Cephalexin for Oral Suspension USP 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.

Regulatory & Marketing

Labeler Name
Jazeera Pharmaceutical
FDA Application #
ANDA065444
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2009
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 (68289-009). Click a package code to view its specific billing and regulatory data.

68289-009-20
200 mL in 1 BOTTLE

* 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 68289-009-01 identifies a specific commercial package of 100 ml in 1 bottle of Cephalexin Usp, labeled by Jazeera Pharmaceutical. 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 Jazeera Pharmaceutical on September 01, 2009. The current certification is valid through December 31, 2017.

How is this Jazeera Pharmaceutical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68289000901. 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)
68289-009-01
11-Digit CMS (5-4-2)
68289-0009-01

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