Zaleplon
NDC Package 0832-0401-00

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 discontinued by the firm.

Zaleplon is a medication used for a short time to treat people who have trouble falling asleep. Marketed by Upsher-smith Laboratories, Inc., this product is identified by NDC 0832-0401 and is authorized under FDA application ANDA078706.

Identification & Billing

NDC Package Code
0832-0401-00
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0832-0401
11-Digit Billing Format
00832040100

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
Upsher-smith Laboratories, Inc.
FDA Application #
ANDA078706
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-06-2008
End Marketing Date
12-15-2008
Listing Expiration
12-15-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0832-0401). Click a package code to view its specific billing and regulatory data.

0832-0401-01
100 BLISTER PACK in 1 CARTON / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (0832-0401-89)
0832-0401-10
1000 CAPSULE, GELATIN COATED 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 0832-0401-00 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Zaleplon, labeled by Upsher-smith Laboratories, 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 Upsher-smith Laboratories, Inc. on June 06, 2008. The current certification is valid through December 15, 2008.

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 Upsher-smith Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00832040100. 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 (4-4-2)
0832-0401-00
11-Digit CMS (5-4-2)
00832-0401-00

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