Edoxaban Tosylate Tablet, Film Coated
NDC Package 66003-202-01

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.

Edoxaban Tosylate tablets is edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). This formulation utilizes a tablet, film coated delivery system. Marketed by Daiichi Sankyo Europe Gmbh, this product is identified by NDC 66003-202.

Identification & Billing

NDC Package Code
66003-202-01
Package Description
119000 TABLET, FILM COATED in 1 DRUM
Product Code
66003-202
11-Digit Billing Format
66003020201

Clinical Specifications

Proprietary Name
Edoxaban Tosylate
Non-Proprietary Name
Edoxaban Tosylate
Substance Name
Edoxaban Tosylate
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)
EDOXABAN TOSYLATE 30 mg/1
Usage Information
Edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). It is also used to treat certain blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE). Edoxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

Regulatory & Marketing

Labeler Name
Daiichi Sankyo Europe Gmbh
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
01-12-2015
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 66003-202-01 identifies a specific commercial package of 119000 tablet, film coated in 1 drum of Edoxaban Tosylate (UNFINISHED drug), drug for further processing labeled by Daiichi Sankyo Europe Gmbh. This tablet, film coated is formulated for use and contains edoxaban tosylate 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 Daiichi Sankyo Europe Gmbh on January 12, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). It is also used to treat certain blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE). Edoxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

How is this Daiichi Sankyo Europe Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66003020201. 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)
66003-202-01
11-Digit CMS (5-4-2)
66003-0202-01

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