NDC Package 45963-568-08 Ezetimibe And Simvastatin

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
45963-568-08
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Ezetimibe And Simvastatin
Non-Proprietary Name:
Ezetimibe And Simvastatin
Substance Name:
Ezetimibe; Simvastatin
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.
11-Digit NDC Billing Format:
45963056808
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 476345 - ezetimibe 10 MG / simvastatin 10 MG Oral Tablet
  • RxCUI: 476349 - ezetimibe 10 MG / simvastatin 20 MG Oral Tablet
  • RxCUI: 476350 - ezetimibe 10 MG / simvastatin 40 MG Oral Tablet
  • RxCUI: 476351 - ezetimibe 10 MG / simvastatin 80 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actavis Pharma, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA202968
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-26-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    45963-568-005000 TABLET in 1 BOX
    45963-568-3030 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45963-568-08?

    The NDC Packaged Code 45963-568-08 is assigned to a package of 90 tablet in 1 bottle of Ezetimibe And Simvastatin, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 45963-568 included in the NDC Directory?

    Yes, Ezetimibe And Simvastatin with product code 45963-568 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on April 26, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45963-568-08?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 45963-568-08?

    The 11-digit format is 45963056808. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245963-568-085-4-245963-0568-08