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  5. NDC Package Code: 83516-0107-1 Exenatide

NDC Package 83516-0107-1 Exenatide

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83516-0107-1
Package Description:
16700000 mg in 1 CONTAINER
Product Code:
83516-0107
Non-Proprietary Name:
Exenatide
Substance Name:
Exenatide
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.
11-Digit NDC Billing Format:
83516010701
Product Type:
Drug For Further Processing
Labeler Name:
Resilience Us, Inc.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
EXENATIDE 5 mg/100mg
Sample Package:
N/A
Marketing Category:
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date:
01-31-2023
End Marketing Date:
06-30-2026
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 83516-0107-1?

The NDC Packaged Code 83516-0107-1 is assigned to an UNFINISHED drug package of 16700000 mg in 1 container of Exenatide, drug for further processing labeled by Resilience Us, Inc.. The product's dosage form is powder and is administered via form.

Is NDC 83516-0107 included in the NDC Directory?

Yes, Exenatide is an UNFINISHED PRODUCT with code 83516-0107 that is active and included in the NDC Directory. The product was first marketed by Resilience Us, Inc. on January 31, 2023.

What is the 11-digit format for NDC 83516-0107-1?

The 11-digit format is 83516010701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-183516-0107-15-4-283516-0107-01