Vytorin Tablet
NDC Package 78206-174-01

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

Vytorin (ezetimibe and simvastatin) tablets is this combination medication is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. This formulation utilizes a tablet delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-174 and is authorized under FDA application NDA021687.

Identification & Billing

NDC Package Code
78206-174-01
Package Description
30 TABLET in 1 BOTTLE
Product Code
78206-174
11-Digit Billing Format
78206017401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vytorin
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
This combination medication is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

Regulatory & Marketing

Labeler Name
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021687
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
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 (78206-174). Click a package code to view its specific billing and regulatory data.

78206-174-02
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 78206-174-01 identifies a specific commercial package of 30 tablet in 1 bottle of Vytorin, a human prescription drug labeled by Organon Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Organon Llc on June 01, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This combination medication is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

How is this Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206017401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
78206-174-01
11-Digit CMS (5-4-2)
78206-0174-01

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