Levemir
NDC Package 68258-8977-1

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 inactivated by the FDA.

Levemir is insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-8977 and is authorized under FDA application NDA021536.

Identification & Billing

NDC Package Code
68258-8977-1
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
68258-8977
11-Digit Billing Format
68258897701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levemir
Dosage Form
-
Usage Information
Insulin detemir 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 detemir 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 detemir may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs (such as metformin, exenatide).

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
NDA021536
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-27-2006
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-8977-1 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Levemir, labeled by Dispensing Solutions, 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 Dispensing Solutions, Inc. on March 27, 2006. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Insulin detemir 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 detemir 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 detemir may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs (such as metformin, exenatide).

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258897701. 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)
68258-8977-1
11-Digit CMS (5-4-2)
68258-8977-01

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