Cephalexin
NDC Package 54348-560-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 discontinued by the firm.

Cephalexin is a medication used to treat a wide variety of bacterial infections. Marketed by Pharmpak, Inc., this product is identified by NDC 54348-560 and is authorized under FDA application ANDA065229.

Identification & Billing

NDC Package Code
54348-560-28
Package Description
1 BOTTLE in 1 BOX / 28 CAPSULE in 1 BOTTLE
Product Code
54348-560
11-Digit Billing Format
54348056028

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Pharmpak, Inc.
FDA Application #
ANDA065229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-12-2019
End Marketing Date
08-31-2021
Listing Expiration
08-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54348-560-28 identifies a specific commercial package of 1 bottle in 1 box / 28 capsule in 1 bottle of Cephalexin, labeled by Pharmpak, 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 Pharmpak, Inc. on July 12, 2019. The current certification is valid through August 31, 2021.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54348056028. 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)
54348-560-28
11-Digit CMS (5-4-2)
54348-0560-28

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