Ezetimibe Tablet
NDC Package 82009-024-05

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

Package Information

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 Quallent Pharmaceuticals Health Llc, this product is identified by NDC 82009-024 and is authorized under FDA application ANDA204331.

Identification & Billing

NDC Package Code
82009-024-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
82009-024
11-Digit Billing Format
82009002405
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
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)
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
Quallent Pharmaceuticals Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204331
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-20-2022
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 82009-024-05 identifies a specific commercial package of 500 tablet in 1 bottle of Ezetimibe, a human prescription drug labeled by Quallent Pharmaceuticals Health 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 Quallent Pharmaceuticals Health Llc on August 20, 2022. 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 Quallent Pharmaceuticals Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82009002405. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
82009-024-05
11-Digit CMS (5-4-2)
82009-0024-05

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