Zaleplon Powder
NDC Package 64330-054-41

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Zaleplon powders is a medication used for a short time to treat people who have trouble falling asleep. This formulation utilizes a powder delivery system. Marketed by Centaur Pharmaceuticals Private Limited, this product is identified by NDC 64330-054.

Identification & Billing

NDC Package Code
64330-054-41
Package Description
19 kg in 1 DRUM
Product Code
64330-054
11-Digit Billing Format
64330005441

Clinical Specifications

Proprietary Name
Zaleplon
Non-Proprietary Name
Zaleplon
Substance Name
Zaleplon
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ZALEPLON 1 kg/kg
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Centaur Pharmaceuticals Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-05-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (64330-054). Click a package code to view its specific billing and regulatory data.

64330-054-07
5 kg in 1 DRUM
64330-054-12
10 kg in 1 DRUM
64330-054-15
25 kg in 1 DRUM
64330-054-27
2.7 kg in 1 DRUM
64330-054-28
2.15 kg in 1 DRUM
64330-054-29
29.7 kg in 1 DRUM
64330-054-30
24 kg in 1 DRUM
64330-054-31
24.5 kg in 1 DRUM
64330-054-32
1.5 kg in 1 DRUM
64330-054-33
28 kg in 1 DRUM
64330-054-34
17.5 kg in 1 DRUM
64330-054-35
18 kg in 1 DRUM
64330-054-36
16 kg in 1 DRUM
64330-054-37
18.5 kg in 1 DRUM
64330-054-38
28.5 kg in 1 DRUM
64330-054-39
29 kg in 1 DRUM
64330-054-40
7 kg in 1 DRUM
64330-054-42
20 kg in 1 DRUM
64330-054-43
19.5 kg in 1 DRUM
64330-054-44
27 kg in 1 DRUM
64330-054-45
23 kg in 1 DRUM

* 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 64330-054-41 identifies a specific commercial package of 19 kg in 1 drum of Zaleplon (UNFINISHED drug), a bulk ingredient labeled by Centaur Pharmaceuticals Private Limited. This powder is formulated for use and contains zaleplon 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 Centaur Pharmaceuticals Private Limited on January 05, 2018. The current certification is valid through December 31, 2026.

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 Centaur Pharmaceuticals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64330005441. 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)
64330-054-41
11-Digit CMS (5-4-2)
64330-0054-41

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