Simvastatin Tablet, Film Coated
NDC Package 60312-0749-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Simvastatin tablets is 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Organon Pharma (uk) Limited, this product is identified by NDC 60312-0749.

Identification & Billing

NDC Package Code
60312-0749-0
Package Description
1 BAG in 1 DRUM / 73000 TABLET, FILM COATED in 1 BAG
Product Code
60312-0749
11-Digit Billing Format
60312074900

Clinical Specifications

Proprietary Name
Simvastatin
Non-Proprietary Name
Simvastatin
Substance Name
Simvastatin
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.
Active Ingredient(s)
SIMVASTATIN 40 mg/1
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.

Regulatory & Marketing

Labeler Name
Organon Pharma (uk) Limited
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-23-1991
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60312-0749-0 identifies a specific commercial package of 1 bag in 1 drum / 73000 tablet, film coated in 1 bag of Simvastatin (UNFINISHED drug), drug for further processing labeled by Organon Pharma (uk) Limited. This tablet, film coated is formulated for use and contains simvastatin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Organon Pharma (uk) Limited on December 23, 1991. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Organon Pharma (uk) Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60312074900. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
60312-0749-0
11-Digit CMS (5-4-2)
60312-0749-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.