Degludec Powder
NDC Package 0420-9007-01

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.

Degludec powders is insulin degludec is used with a proper diet and exercise program to control high blood sugar in people with diabetes. This formulation utilizes a powder delivery system. Marketed by Novo Nordisk A/s, this product is identified by NDC 0420-9007.

Identification & Billing

NDC Package Code
0420-9007-01
Package Description
1600 g in 1 CONTAINER
Product Code
0420-9007
11-Digit Billing Format
00420900701

Clinical Specifications

Proprietary Name
Degludec
Non-Proprietary Name
Degludec
Substance Name
Insulin Degludec
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
INSULIN DEGLUDEC 1 g/g
Usage Information
Insulin degludec is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin degludec is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin degludec may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

Regulatory & Marketing

Labeler Name
Novo Nordisk A/s
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-20-2012
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 0420-9007-01 identifies a specific commercial package of 1600 g in 1 container of Degludec (UNFINISHED drug), a bulk ingredient labeled by Novo Nordisk A/s. This powder is formulated for use and contains insulin degludec 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 Novo Nordisk A/s on July 20, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Insulin degludec is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin degludec is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin degludec may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

How is this Novo Nordisk A/s product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00420900701. 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 (4-4-2)
0420-9007-01
11-Digit CMS (5-4-2)
00420-9007-01

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