Cephalexin Capsule
NDC Package 72287-310-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cephalexin capsules is a medication used to treat a wide variety of bacterial infections. This formulation utilizes a capsule delivery system. Marketed by Amella Pharma, Llc, this product is identified by NDC 72287-310 and is authorized under FDA application ANDA065253.

Identification & Billing

NDC Package Code
72287-310-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
72287-310
11-Digit Billing Format
72287031001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Non-Proprietary Name
Cephalexin
Substance Name
Cephalexin
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CEPHALEXIN 500 mg/1
Pharmacologic Class
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
Amella Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065253
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 72287-310-01 identifies a specific commercial package of 100 capsule in 1 bottle of Cephalexin, a human prescription drug labeled by Amella Pharma, Llc. This capsule is formulated for oral use and contains cephalexin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amella Pharma, Llc on June 27, 2018. The current certification is valid through December 31, 2026.

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 Amella Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72287031001. 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)
72287-310-01
11-Digit CMS (5-4-2)
72287-0310-01

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