Cephalexin
NDC Package 67296-0976-1

11-digit billing NDC: 67296097601
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 1.1 Respiratory Tract InfectionsCephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.1.2 Otitis MediaCephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes,and Mo raxella catarrhalis.1.3 Skin and Skin Structure InfectionsCephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.1.4 Bone InfectionsCephalexin is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.1.5 Genitourinary Tract InfectionsCephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e.1.6 UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Redpharm Drug, Inc., this product is identified by NDC 67296-0976 and is authorized under FDA application ANDA090836.

Identification & Billing

NDC Package Code
67296-0976-1
Package Description
10 CAPSULE in 1 BOTTLE
Product Code
67296-0976
11-Digit Billing Format
67296097601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
1.1 Respiratory Tract InfectionsCephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.1.2 Otitis MediaCephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes,and Mo raxella catarrhalis.1.3 Skin and Skin Structure InfectionsCephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.1.4 Bone InfectionsCephalexin is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.1.5 Genitourinary Tract InfectionsCephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e.1.6 UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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
Redpharm Drug, Inc.
FDA Application #
ANDA090836
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2018
Listing Expiration
12-31-2025
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 (67296-0976). Click a package code to view its specific billing and regulatory data.

67296-0976-2
20 CAPSULE in 1 BOTTLE
67296-0976-3
30 CAPSULE in 1 BOTTLE
67296-0976-4
40 CAPSULE in 1 BOTTLE
67296-0976-5
14 CAPSULE in 1 BOTTLE
67296-0976-6
28 CAPSULE in 1 BOTTLE
67296-0976-7
15 CAPSULE 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 67296-0976-1 identifies a specific commercial package of 10 capsule in 1 bottle of Cephalexin, labeled by Redpharm Drug, 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 Redpharm Drug, Inc. on January 01, 2018. The current certification is valid through December 31, 2025.

How is this Redpharm Drug, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296097601. 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)
67296-0976-1
11-Digit CMS (5-4-2)
67296-0976-01

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