Temazepam
NDC Package 70518-2008-0

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 discontinued by the firm.

Temazepam is a medication used to treat a certain sleep problem (insomnia). Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2008 and is authorized under FDA application ANDA071457.

Identification & Billing

NDC Package Code
70518-2008-0
Package Description
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
70518-2008
11-Digit Billing Format
70518200800

Clinical Specifications

Proprietary Name
Temazepam
Dosage Form
-
Usage Information
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA071457
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-11-2019
End Marketing Date
12-22-2021
Listing Expiration
12-22-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-2008-0 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Temazepam, 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 April 11, 2019. The current certification is valid through December 22, 2021.

What are the primary indications for this medication?

This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518200800. 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)
70518-2008-0
11-Digit CMS (5-4-2)
70518-2008-00

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