Levemir
NDC Package 54868-5883-0
Package Information
Levemir is insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5883 and is authorized under FDA application NDA021536.
Identification & Billing
- RxCUI: 847239 - insulin detemir 100 UNT/ML in 3 ML Pen Injector
- RxCUI: 847239 - 3 ML insulin detemir 100 UNT/ML Pen Injector
- RxCUI: 847241 - Levemir 100 UNT/ML in 3 ML Pen Injector
- RxCUI: 847241 - 3 ML insulin detemir 100 UNT/ML Pen Injector [Levemir]
- RxCUI: 847241 - 3 ML Levemir 100 UNT/ML Pen Injector
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-5883 - Levemir
- 54868-5883-0 - 5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC
- 54868-5883 - Levemir
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 54868-5883-0 identifies a specific commercial package of 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic of Levemir, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on March 31, 2008. 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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868588300. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
