Ramelteon Tablet, Film Coated
NDC Package 66332-0014-5

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ramelteon tablets is a medication used to treat sleeplessness (insomnia). This formulation utilizes a tablet, film coated delivery system. Marketed by Takeda Ireland Ltd., this product is identified by NDC 66332-0014.

Identification & Billing

NDC Package Code
66332-0014-5
Package Description
120000 TABLET, FILM COATED in 1 DRUM
Product Code
66332-0014
11-Digit Billing Format
66332001405

Clinical Specifications

Proprietary Name
Ramelteon
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.
Active Ingredient(s)
RAMELTEON 8 mg/1
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 Ireland Ltd.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-22-2005
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 66332-0014-5 identifies a specific commercial package of 120000 tablet, film coated in 1 drum of Ramelteon (UNFINISHED drug), drug for further processing labeled by Takeda Ireland Ltd.. This tablet, film coated is formulated for 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 Ireland Ltd. on July 22, 2005. The current certification is valid through December 31, 2026.

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 Ireland Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66332001405. 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)
66332-0014-5
11-Digit CMS (5-4-2)
66332-0014-05

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