Byetta Injection
NDC Package 0310-6512-85

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

Byetta (exenatide) injection is exenatide is used with a proper diet and exercise program to control high blood sugar. This formulation utilizes a injection delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-6512 and is authorized under FDA application NDA021773.

Identification & Billing

NDC Package Code
0310-6512-85
Package Description
1 CARTRIDGE in 1 CARTON / 1.2 mL in 1 CARTRIDGE
Product Code
0310-6512
11-Digit Billing Format
00310651285
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Byetta
Non-Proprietary Name
Exenatide
Substance Name
Exenatide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
EXENATIDE 250 ug/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA021773
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-10-2014
End Marketing Date
12-31-2026
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 (0310-6512). Click a package code to view its specific billing and regulatory data.

0310-6512-01
1 CARTRIDGE in 1 CARTON / 1.2 mL in 1 CARTRIDGE

* 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 0310-6512-85 identifies a specific commercial package of 1 cartridge in 1 carton / 1.2 ml in 1 cartridge of Byetta, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This injection is formulated for subcutaneous use and contains exenatide 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 Astrazeneca Pharmaceuticals Lp on December 10, 2014.

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 Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310651285. 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)
0310-6512-85
11-Digit CMS (5-4-2)
00310-6512-85

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