Zetia Tablet
NDC Package 78206-178-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zetia (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 Organon Llc, this product is identified by NDC 78206-178 and is authorized under FDA application NDA021445.

Identification & Billing

NDC Package Code
78206-178-01
Package Description
30 TABLET in 1 BOTTLE
Product Code
78206-178
11-Digit Billing Format
78206017801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zetia
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)
EZETIMIBE 10 mg/1
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
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021445
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 78206-178-01 identifies a specific commercial package of 30 tablet in 1 bottle of Zetia, a human prescription drug labeled by Organon Llc. 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 Organon Llc on June 01, 2021. The current certification is valid through December 31, 2026.

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 Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206017801. 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)
78206-178-01
11-Digit CMS (5-4-2)
78206-0178-01

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