Levemir Injection, Solution
NDC Package 0169-3687-12

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Levemir (insulin detemir) injection is insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. This formulation utilizes a injection, solution delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-3687 and is authorized under FDA application BLA021536.

Identification & Billing

NDC Package Code
0169-3687-12
Package Description
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code
0169-3687
11-Digit Billing Format
00169368712
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levemir
Non-Proprietary Name
Insulin Detemir
Substance Name
Insulin Detemir
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
INSULIN DETEMIR 100 [iU]/mL
Pharmacologic Class
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
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
BLA021536
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-27-2006
End Marketing Date
08-31-2026
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 (0169-3687). Click a package code to view its specific billing and regulatory data.

0169-3687-92
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

* 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 0169-3687-12 identifies a specific commercial package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Levemir, a human prescription drug labeled by Novo Nordisk. This injection, solution is formulated for subcutaneous use and contains insulin detemir 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 on March 27, 2006.

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 Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169368712. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0169-3687-12
11-Digit CMS (5-4-2)
00169-3687-12

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