Zolpidem Tartrate
NDC Package 70518-1663-2

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.

Zolpidem Tartrate is zolpidem is used to treat a certain sleep problem (insomnia) in adults. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-1663 and is authorized under FDA application ANDA076410.

Identification & Billing

NDC Package Code
70518-1663-2
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
70518-1663
11-Digit Billing Format
70518166302

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
Remedyrepack Inc.
FDA Application #
ANDA076410
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-12-2018
End Marketing Date
05-05-2024
Listing Expiration
05-05-2024
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 (70518-1663). Click a package code to view its specific billing and regulatory data.

70518-1663-0
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
70518-1663-1
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 70518-1663-2 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Zolpidem Tartrate, labeled by Remedyrepack 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 Remedyrepack Inc. on November 12, 2018. The current certification is valid through May 05, 2024.

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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518166302. 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)
70518-1663-2
11-Digit CMS (5-4-2)
70518-1663-02

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