Ezetimibe And Simvastatin Tablet
NDC Package 59651-835-30

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

Ezetimibe And Simvastatin tablets is  Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia. This formulation utilizes a tablet delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 59651-835 and is authorized under FDA application ANDA200082.

Identification & Billing

NDC Package Code
59651-835-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
59651-835
11-Digit Billing Format
59651083530
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ezetimibe And Simvastatin
Non-Proprietary Name
Ezetimibe And Simvastatin
Substance Name
Ezetimibe; Simvastatin
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 and simvastatin tablets  Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). SimvastatinSimvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA200082
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2024
Listing Expiration
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 (59651-835). Click a package code to view its specific billing and regulatory data.

59651-835-90
90 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 59651-835-30 identifies a specific commercial package of 30 tablet in 1 bottle of Ezetimibe And Simvastatin, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet is formulated for oral use and contains ezetimibe; simvastatin 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 Aurobindo Pharma Limited on March 01, 2024. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59651083530. 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 (5-3-2)
59651-835-30
11-Digit CMS (5-4-2)
59651-0835-30

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