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  5. NDC Package Code: 59651-835-90 Ezetimibe And Simvastatin

NDC Package 59651-835-90 Ezetimibe And Simvastatin

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
59651-835-90
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
59651-835
Proprietary Name:
Ezetimibe And Simvastatin
Non-Proprietary Name:
Ezetimibe And Simvastatin
Substance Name:
Ezetimibe; Simvastatin
Usage Information:
Ezetimibe and simvastatin tablets  Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). SimvastatinSimvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
11-Digit NDC Billing Format:
59651083590
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:
    Aurobindo Pharma Limited
    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.
    • Active Ingredient(s):
  • EZETIMIBE 10 mg/1
  • SIMVASTATIN 10 mg/1
    • Pharmacologic Class(es):
  • Decreased Cholesterol Absorption - [PE] (Physiologic Effect)
  • Dietary Cholesterol Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • HMG-CoA Reductase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA200082
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2024
    Listing Expiration Date:
    12-31-2025
    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
    59651-835-3030 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59651-835-90?

    The NDC Packaged Code 59651-835-90 is assigned to a package of 90 tablet in 1 bottle of Ezetimibe And Simvastatin, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 59651-835 included in the NDC Directory?

    Yes, Ezetimibe And Simvastatin with product code 59651-835 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on March 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59651-835-90?

    The 11-digit format is 59651083590. 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
    5-3-259651-835-905-4-259651-0835-90