Gemfibrozil Tablet, Film Coated
NDC Package 16571-784-50

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

Package Information

Gemfibrozil tablets is gemfibrozil is used along with a proper diet to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in the blood. This formulation utilizes a tablet, film coated delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-784 and is authorized under FDA application ANDA202726.

Identification & Billing

NDC Package Code
16571-784-50
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
16571-784
11-Digit Billing Format
16571078450
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk
RxCUI: 310459 - gemfibrozil 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Gemfibrozil
Non-Proprietary Name
Gemfibrozil
Substance Name
Gemfibrozil
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GEMFIBROZIL 600 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202726
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-16-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16571-784). Click a package code to view its specific billing and regulatory data.

16571-784-06
60 TABLET, FILM COATED in 1 BOTTLE

* 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 16571-784-50 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Gemfibrozil, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This tablet, film coated is formulated for oral use and contains gemfibrozil 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 Rising Pharma Holdings, Inc. on September 16, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571078450. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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 (5-3-2)
16571-784-50
11-Digit CMS (5-4-2)
16571-0784-50

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