Ezetimibe And Simvastatin
NDC Package 42291-080-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ezetimibe And Simvastatin is therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Marketed by Avkare, this product is identified by NDC 42291-080 and is authorized under FDA application ANDA208831.

Identification & Billing

NDC Package Code
42291-080-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
42291-080
11-Digit Billing Format
42291008010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA

Clinical Specifications

Proprietary Name
Ezetimibe And Simvastatin
Dosage Form
-
Usage Information
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA208831
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-04-2022
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
Exclude Flag
D
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 42291-080-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Ezetimibe And Simvastatin, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avkare on October 04, 2022. The current certification is valid through April 30, 2026.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291008010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
42291-080-10
11-Digit CMS (5-4-2)
42291-0080-10

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