Ezetimibe Powder
NDC Package 65096-0113-5

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

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.

Ezetimibe powders is ezetimibe is used along with a low cholesterol/low fat diet and exercise to help lower cholesterol in the blood. This formulation utilizes a powder delivery system. Marketed by Synthimed Labs Private Limited, this product is identified by NDC 65096-0113.

Identification & Billing

NDC Package Code
65096-0113-5
Package Description
25 kg in 1 DRUM
Product Code
65096-0113
11-Digit Billing Format
65096011305

Clinical Specifications

Proprietary Name
Ezetimibe
Non-Proprietary Name
Ezetimibe
Substance Name
Ezetimibe
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)
EZETIMIBE 1 kg/kg
Usage Information
Ezetimibe is used along with a low cholesterol/low fat diet and exercise to help lower cholesterol in the blood. Ezetimibe may be used alone or with other drugs (such as "statins" or fibrates). Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Reducing cholesterol may help prevent strokes and heart attacks.

Regulatory & Marketing

Labeler Name
Synthimed Labs Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-01-2010
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (65096-0113). Click a package code to view its specific billing and regulatory data.

65096-0113-1
1 kg in 1 DRUM
65096-0113-2
5 kg in 1 DRUM
65096-0113-3
10 kg in 1 DRUM
65096-0113-4
20 kg in 1 DRUM

* 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 65096-0113-5 identifies a specific commercial package of 25 kg in 1 drum of Ezetimibe (UNFINISHED drug), a bulk ingredient labeled by Synthimed Labs Private Limited. This powder is formulated for use and contains ezetimibe 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 Synthimed Labs Private Limited on December 01, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Ezetimibe is used along with a low cholesterol/low fat diet and exercise to help lower cholesterol in the blood. Ezetimibe may be used alone or with other drugs (such as "statins" or fibrates). Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Reducing cholesterol may help prevent strokes and heart attacks.

How is this Synthimed Labs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65096011305. 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)
65096-0113-5
11-Digit CMS (5-4-2)
65096-0113-05

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