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  5. NDC Package Code: 65862-769-78 Fenofibrate

NDC Package 65862-769-78 Fenofibrate

Tablet, Coated 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:
65862-769-78
Package Description:
10 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK (65862-769-10)
Product Code:
65862-769
Proprietary Name:
Fenofibrate
Non-Proprietary Name:
Fenofibrate
Substance Name:
Fenofibrate
Usage Information:
Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
11-Digit NDC Billing Format:
65862076978
NDC to RxNorm Crosswalk:
  • RxCUI: 477560 - fenofibrate 145 MG Oral Tablet
  • RxCUI: 477562 - fenofibrate 48 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FENOFIBRATE 145 mg/1
  • FENOFIBRATE 145 mg/1
    • Pharmacologic Class(es):
  • Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205118
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-05-2016
    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
    65862-769-01100 TABLET, COATED in 1 BOTTLE
    65862-769-05500 TABLET, COATED in 1 BOTTLE
    65862-769-151500 TABLET, COATED in 1 BAG
    65862-769-9090 TABLET, COATED in 1 BOTTLE
    65862-769-991000 TABLET, COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-769-78?

    The NDC Packaged Code 65862-769-78 is assigned to a package of 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack (65862-769-10) of Fenofibrate, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 65862-769 included in the NDC Directory?

    Yes, Fenofibrate with product code 65862-769 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on May 05, 2016 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 11-digit format for NDC 65862-769-78?

    The 11-digit format is 65862076978. 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
    5-3-265862-769-785-4-265862-0769-78