Morphabond
NDC Package 65597-302-10

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 discontinued by the firm.

Morphabond is a medication used to help relieve severe ongoing pain (such as due to cancer). Marketed by Daiichi Sankyo Inc., this product is identified by NDC 65597-302 and is authorized under FDA application NDA206544.

Identification & Billing

NDC Package Code
65597-302-10
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
65597-302
11-Digit Billing Format
65597030210
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Morphabond ER
Dosage Form
-
Usage Information
This medication is used to help relieve severe ongoing pain (such as due to cancer). Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. The higher strengths of this drug (100 milligrams or more per tablet) should be used only if you have been regularly taking moderate to large amounts of opioid pain medications. These strengths may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the extended-release form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Regulatory & Marketing

Labeler Name
Daiichi Sankyo Inc.
FDA Application #
NDA206544
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-02-2017
End Marketing Date
01-22-2021
Listing Expiration
01-22-2021
Exclude Flag
D
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 65597-302-10 identifies a specific commercial package of 100 tablet, extended release in 1 bottle, plastic of Morphabond ER, labeled by Daiichi Sankyo Inc.. 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 Daiichi Sankyo Inc. on March 02, 2017. The current certification is valid through January 22, 2021.

What are the primary indications for this medication?

This medication is used to help relieve severe ongoing pain (such as due to cancer). Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. The higher strengths of this drug (100 milligrams or more per tablet) should be used only if you have been regularly taking moderate to large amounts of opioid pain medications. These strengths may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the extended-release form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Daiichi Sankyo Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597030210. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
65597-302-10
11-Digit CMS (5-4-2)
65597-0302-10

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