NDC Package 35561-346-11 Fenofibrate

Capsule 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:
35561-346-11
Package Description:
90 CAPSULE in 1 BOTTLE
Product Code:
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:
35561034611
NDC to RxNorm Crosswalk:
  • RxCUI: 200311 - fenofibrate 67 MG Oral Capsule
  • RxCUI: 310288 - fenofibrate 134 MG Oral Capsule
  • RxCUI: 310289 - fenofibrate 200 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Austarpharma, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA207805
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-17-2017
    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
    35561-346-12100 CAPSULE in 1 BOTTLE
    35561-346-13500 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 35561-346-11?

    The NDC Packaged Code 35561-346-11 is assigned to a package of 90 capsule in 1 bottle of Fenofibrate, a human prescription drug labeled by Austarpharma, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 35561-346 included in the NDC Directory?

    Yes, Fenofibrate with product code 35561-346 is active and included in the NDC Directory. The product was first marketed by Austarpharma, Llc on November 17, 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 11-digit format for NDC 35561-346-11?

    The 11-digit format is 35561034611. 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
    5-3-235561-346-115-4-235561-0346-11