Cephalexin
NDC Package 42549-565-04

11-digit billing NDC: 42549056504 · Billing unit: EA · 4 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.

Cephalexin 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 Stat Rx Usa Llc, this product is identified by NDC 42549-565 and is authorized under FDA application ANDA062702.

Identification & Billing

NDC Package Code
42549-565-04
Package Description
4 CAPSULE in 1 BOTTLE
Product Code
42549-565
11-Digit Billing Format
42549056504
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
Cephalexin 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 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 Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote—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 capsules, cephalexin for oral suspension, cephalexin tablets, and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets 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
Stat Rx Usa Llc
FDA Application #
ANDA062702
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-28-2011
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 (42549-565). Click a package code to view its specific billing and regulatory data.

42549-565-10
10 CAPSULE in 1 BOTTLE
42549-565-28
28 CAPSULE in 1 BOTTLE
42549-565-30
30 CAPSULE in 1 BOTTLE
42549-565-40
40 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 42549-565-04 identifies a specific commercial package of 4 capsule in 1 bottle of Cephalexin, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 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 Stat Rx Usa Llc on January 28, 2011. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42549056504. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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 (5-3-2)
42549-565-04
11-Digit CMS (5-4-2)
42549-0565-04

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