Zolpidem Tartrate
NDC Package 67296-0803-1

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zolpidem Tartrate is zolpidem is used to treat a certain sleep problem (insomnia) in adults. Marketed by Redpharm Drug Inc., this product is identified by NDC 67296-0803 and is authorized under FDA application ANDA078616.

Identification & Billing

NDC Package Code
67296-0803-1
Package Description
10 TABLET, FILM COATED in 1 BOTTLE
Product Code
67296-0803
11-Digit Billing Format
67296080301
RxNorm Crosswalk
RxCUI: 854876 - zolpidem tartrate 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Zolpidem Tartrate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Redpharm Drug Inc.
FDA Application #
ANDA078616
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-0803-1 identifies a specific commercial package of 10 tablet, film coated in 1 bottle of Zolpidem Tartrate, labeled by Redpharm Drug 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 Redpharm Drug Inc. on November 21, 2008. The current certification is valid through December 31, 2017.

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 Redpharm Drug Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296080301. 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)
67296-0803-1
11-Digit CMS (5-4-2)
67296-0803-01

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