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  5. NDC Package Code: 53002-2068-0 Gemfibrozil

NDC Package 53002-2068-0 Gemfibrozil

Tablet, Film 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:
53002-2068-0
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
53002-2068
Proprietary Name:
Gemfibrozil
Non-Proprietary Name:
Gemfibrozil
Substance Name:
Gemfibrozil
Usage Information:
Gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. It may also help to lower "bad" cholesterol (LDL). Gemfibrozil belongs to a group of drugs known as "fibrates." It works by decreasing the amount of fat produced by the liver. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, gemfibrozil might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of gemfibrozil. 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, drinking less alcohol, losing weight if overweight, and stopping smoking.
11-Digit NDC Billing Format:
53002206800
NDC to RxNorm Crosswalk:
  • RxCUI: 310459 - gemfibrozil 600 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GEMFIBROZIL 600 mg/1
    • Pharmacologic Class(es):
  • PPAR alpha - [CS]
  • Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
  • Peroxisome Proliferator-activated Receptor alpha Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202726
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-16-2015
    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
    53002-2068-660 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-2068-0?

    The NDC Packaged Code 53002-2068-0 is assigned to a package of 100 tablet, film coated in 1 bottle of Gemfibrozil, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 53002-2068 included in the NDC Directory?

    Yes, Gemfibrozil with product code 53002-2068 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on September 16, 2015 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 53002-2068-0?

    The 11-digit format is 53002206800. 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 5-4-1 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
    5-4-153002-2068-05-4-253002-2068-00