Ezetimibe Tablet
NDC Package 0591-3713-00

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ezetimibe tablets 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 tablet delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-3713 and is authorized under FDA application ANDA200831.

Identification & Billing

NDC Package Code
0591-3713-00
Package Description
100000 TABLET in 1 BOX
Product Code
0591-3713
11-Digit Billing Format
00591371300
RxNorm Crosswalk
RxCUI: 349556 - ezetimibe 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ezetimibe
Non-Proprietary Name
Ezetimibe
Substance Name
Ezetimibe
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200831
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2017
End Marketing Date
07-31-2026
Exclude Flag
N
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 (0591-3713). Click a package code to view its specific billing and regulatory data.

0591-3713-05
500 TABLET in 1 BOTTLE
0591-3713-19
90 TABLET in 1 BOTTLE
0591-3713-30
30 TABLET in 1 BOTTLE

* 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 0591-3713-00 identifies a specific commercial package of 100000 tablet in 1 box of Ezetimibe, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet is formulated for oral 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 Actavis Pharma, Inc. on June 12, 2017.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591371300. 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)
0591-3713-00
11-Digit CMS (5-4-2)
00591-3713-00

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