Cephalexin
NDC Package 63304-656-27

11-digit billing NDC: 63304065627
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 discontinued by the firm.

Cephalexin is to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Ranbaxy Pharmaceuticals Inc., this product is identified by NDC 63304-656 and is authorized under FDA application ANDA065007.

Identification & Billing

NDC Package Code
63304-656-27
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
63304-656
11-Digit Billing Format
63304065627
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension 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.Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci and M. catarrhalisSkin and skin structure infections caused by staphylococci and/or streptococciBone infections caused by staphylococci and/or P. mirabilisGenitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

Regulatory & Marketing

Labeler Name
Ranbaxy Pharmaceuticals Inc.
FDA Application #
ANDA065007
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-28-1998
End Marketing Date
08-29-2011
Listing Expiration
08-29-2011
Exclude Flag
D
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 (63304-656). Click a package code to view its specific billing and regulatory data.

63304-656-01
100 CAPSULE in 1 BOTTLE
63304-656-05
500 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 63304-656-27 identifies a specific commercial package of 28 capsule in 1 bottle of Cephalexin, labeled by Ranbaxy Pharmaceuticals 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 Ranbaxy Pharmaceuticals Inc. on July 28, 1998. The current certification is valid through August 29, 2011.

How is this Ranbaxy Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304065627. 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)
63304-656-27
11-Digit CMS (5-4-2)
63304-0656-27

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