Byetta
NDC Package 54868-5384-0
Package Information
Byetta is exenatide is used with a proper diet and exercise program to control high blood sugar. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5384 and is authorized under FDA application NDA021773.
Identification & Billing
- RxCUI: 847910 - exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector
- RxCUI: 847910 - 60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector
- RxCUI: 847910 - exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUAT
- RxCUI: 847910 - exenatide 250 MCG/ML Pen Injector, 2.4 ML
- RxCUI: 847913 - Byetta 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-5384 - Byetta
- 54868-5384-0 - 1.2 mL in 1 CARTRIDGE
- 54868-5384 - Byetta
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 (54868-5384). Click a package code to view its specific billing and regulatory data.
* 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 54868-5384-0 identifies a specific commercial package of 1.2 ml in 1 cartridge of Byetta, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1.2 billable units per package. 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 August 09, 2005. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
Exenatide is used with a proper diet and exercise program to control high blood sugar. It is used by people with type 2 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. Exenatide is a diabetes drug that is similar to a natural hormone in your body (incretin). It works by increasing insulin release (especially after a meal) and decreasing the amount of sugar your liver makes. It also slows down food digestion in your stomach, decreases the amount of sugar absorbed from food, and may help decrease your appetite.
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: 54868538400. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1.2 total billable units per package. 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.
