Levemir
NDC Package 70518-1387-0

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.

Levemir is insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-1387 and is authorized under FDA application BLA021536.

Identification & Billing

NDC Package Code
70518-1387-0
Package Description
5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC
Product Code
70518-1387
11-Digit Billing Format
70518138700

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
Remedyrepack Inc.
FDA Application #
BLA021536
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-27-2018
End Marketing Date
03-09-2020
Listing Expiration
03-09-2020
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 70518-1387-0 identifies a specific commercial package of 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic of Levemir, labeled by Remedyrepack 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 Remedyrepack Inc. on August 27, 2018. The current certification is valid through March 09, 2020.

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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518138700. 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)
70518-1387-0
11-Digit CMS (5-4-2)
70518-1387-00

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