Savaysa Tablet, Film Coated
NDC Package 65597-201-07

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

Savaysa (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 Inc., this product is identified by NDC 65597-201 and is authorized under FDA application NDA206316.

Identification & Billing

NDC Package Code
65597-201-07
Package Description
7 TABLET, FILM COATED in 1 BOTTLE
Product Code
65597-201
11-Digit Billing Format
65597020107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Savaysa
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EDOXABAN TOSYLATE 15 mg/1
Pharmacologic Class
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 Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206316
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-12-2015
Listing Expiration
12-31-2026
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 (65597-201). Click a package code to view its specific billing and regulatory data.

65597-201-10
10 TABLET, FILM COATED in 1 BLISTER PACK
65597-201-30
30 TABLET, FILM COATED in 1 BOTTLE
65597-201-50
500 TABLET, FILM COATED in 1 BOTTLE
65597-201-70
7 TABLET, FILM COATED in 1 BLISTER PACK
65597-201-90
90 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 65597-201-07 identifies a specific commercial package of 7 tablet, film coated in 1 bottle of Savaysa, a human prescription drug labeled by Daiichi Sankyo Inc.. This tablet, film coated is formulated for oral 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 Inc. 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 Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597020107. 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)
65597-201-07
11-Digit CMS (5-4-2)
65597-0201-07

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