Zolpidem Tartrate Powder
NDC Package 66039-810-03

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 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.

Zolpidem Tartrate powders is zolpidem is used to treat a certain sleep problem (insomnia) in adults. This formulation utilizes a powder delivery system. Marketed by Alivus Life Sciences Limited, this product is identified by NDC 66039-810.

Identification & Billing

NDC Package Code
66039-810-03
Package Description
50 kg in 1 DRUM
Product Code
66039-810
11-Digit Billing Format
66039081003

Clinical Specifications

Proprietary Name
Zolpidem Tartrate
Non-Proprietary Name
Zolpidem Tartrate
Substance Name
Zolpidem Tartrate
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)
ZOLPIDEM TARTRATE 1 kg/kg
Usage Information
Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Alivus Life Sciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-14-2005
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66039-810-03 identifies a specific commercial package of 50 kg in 1 drum of Zolpidem Tartrate (UNFINISHED drug), a bulk ingredient labeled by Alivus Life Sciences Limited. This powder is formulated for use and contains zolpidem tartrate 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 Alivus Life Sciences Limited on March 14, 2005. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

How is this Alivus Life Sciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66039081003. 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)
66039-810-03
11-Digit CMS (5-4-2)
66039-0810-03

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