Rozerem Tablet, Film Coated
NDC Package 64764-805-22

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

Rozerem (ramelteon) tablets is a medication used to treat sleeplessness (insomnia). This formulation utilizes a tablet, film coated delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-805 and is authorized under FDA application NDA021782.

Identification & Billing

NDC Package Code
64764-805-22
Package Description
6 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
64764-805
11-Digit Billing Format
64764080522
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rozerem
Non-Proprietary Name
Ramelteon
Substance Name
Ramelteon
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RAMELTEON 8 mg/1
Pharmacologic Class
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
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021782
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-22-2005
Listing Expiration
12-31-2027
Exclude Flag
N
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 (64764-805). Click a package code to view its specific billing and regulatory data.

64764-805-10
100 TABLET, FILM COATED in 1 BOTTLE
64764-805-30
30 TABLET, FILM COATED in 1 BOTTLE

* 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 64764-805-22 identifies a specific commercial package of 6 carton in 1 tray / 1 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Rozerem, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This tablet, film coated is formulated for oral use and contains ramelteon 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 Takeda Pharmaceuticals America, Inc. on July 22, 2005. The current certification is valid through December 31, 2027.

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 Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764080522. 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)
64764-805-22
11-Digit CMS (5-4-2)
64764-0805-22

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