Rozerem
NDC Package 68151-4881-1

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.

Rozerem is a medication used to treat sleeplessness (insomnia). Marketed by Carilion Materials Management, this product is identified by NDC 68151-4881 and is authorized under FDA application NDA021782.

Identification & Billing

NDC Package Code
68151-4881-1
Package Description
1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
68151-4881
11-Digit Billing Format
68151488101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rozerem
Dosage Form
-
Usage Information
This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

Regulatory & Marketing

Labeler Name
Carilion Materials Management
FDA Application #
NDA021782
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-22-2005
Listing Expiration
12-31-2018
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 68151-4881-1 identifies a specific commercial package of 1 tablet, film coated in 1 blister pack of Rozerem, labeled by Carilion Materials Management. 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 Carilion Materials Management on July 22, 2005. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

How is this Carilion Materials Management product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68151488101. 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)
68151-4881-1
11-Digit CMS (5-4-2)
68151-4881-01

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