NDC Package 42658-111-04 Simvastatin

Tablet, Film Coated 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:
42658-111-04
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Simvastatin
Non-Proprietary Name:
Simvastatin
Substance Name:
Simvastatin
Usage Information:
Simvastatin 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 belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. 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:
42658011104
NDC to RxNorm Crosswalk:
  • RxCUI: 198211 - simvastatin 40 MG Oral Tablet
  • RxCUI: 200345 - simvastatin 80 MG Oral Tablet
  • RxCUI: 312961 - simvastatin 20 MG Oral Tablet
  • RxCUI: 314231 - simvastatin 10 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hisun Pharmaceuticals Usa, 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):
    Sample Package:
    No
    FDA Application Number:
    ANDA206557
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2020
    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
    42658-111-0130 TABLET, FILM COATED in 1 BOTTLE
    42658-111-081000 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42658-111-04?

    The NDC Packaged Code 42658-111-04 is assigned to a package of 90 tablet, film coated in 1 bottle of Simvastatin, a human prescription drug labeled by Hisun Pharmaceuticals Usa, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 42658-111 included in the NDC Directory?

    Yes, Simvastatin with product code 42658-111 is active and included in the NDC Directory. The product was first marketed by Hisun Pharmaceuticals Usa, Inc. on May 01, 2020 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 42658-111-04?

    The 11-digit format is 42658011104. 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
    5-3-242658-111-045-4-242658-0111-04