Cephalexin
NDC Package 50436-7216-3

11-digit billing NDC: 50436721603
Table of Contents
    1. Package Information
    2. 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 capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Marketed by Unit Dose Services, this product is identified by NDC 50436-7216 and is authorized under FDA application ANDA062791.

Identification & Billing

NDC Package Code
50436-7216-3
Package Description
40 CAPSULE in 1 BOTTLE
Product Code
50436-7216
11-Digit Billing Format
50436721603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — 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, USP and other antibacterial drugs, cephalexin capsules, 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.Streptococcus pneumoniaeStreptococcus pyogenesStreptococcus pneumoniaeHaemophilus influenzaeStaphylococcus aureus, Streptococcus pyogenesMoraxella catarrhalisStaphylococcus aureusStreptococcus pyogenesStaphylococcus aureusProteus mirabilisEscherichia coliProteus mirabilisKlebsiella pneumoniaeNote

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA062791
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2010
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50436-7216-3 identifies a specific commercial package of 40 capsule in 1 bottle of Cephalexin, labeled by Unit Dose Services. 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 Unit Dose Services on June 21, 2010. The current certification is valid through December 31, 2019.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436721603. 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)
50436-7216-3
11-Digit CMS (5-4-2)
50436-7216-03

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