Zaleplon
NDC Package 54868-5909-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Zaleplon is a medication used for a short time to treat people who have trouble falling asleep. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5909 and is authorized under FDA application ANDA078829.

Identification & Billing

NDC Package Code
54868-5909-0
Package Description
10 CAPSULE in 1 BOTTLE
Product Code
54868-5909
11-Digit Billing Format
54868590900
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zaleplon
Dosage Form
-
Usage Information
This medication is used for a short time to treat people who have trouble falling asleep. If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you. Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA078829
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2008
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 (54868-5909). Click a package code to view its specific billing and regulatory data.

54868-5909-1
30 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 54868-5909-0 identifies a specific commercial package of 10 capsule in 1 bottle of Zaleplon, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on June 19, 2008. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used for a short time to treat people who have trouble falling asleep. If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you. Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868590900. 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)
54868-5909-0
11-Digit CMS (5-4-2)
54868-5909-00

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