Fluvastatin Sodium Tablet, Film Coated, Extended Release
NDC Package 0093-7446-01

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

Fluvastatin Sodium tablets is fluvastatin 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, extended release delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-7446 and is authorized under FDA application ANDA079011.

Identification & Billing

NDC Package Code
0093-7446-01
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
0093-7446
11-Digit Billing Format
00093744601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 360507 - fluvastatin sodium 80 MG 24HR Extended Release Oral Tablet
  • RxCUI: 360507 - 24 HR fluvastatin 80 MG Extended Release Oral Tablet
  • RxCUI: 360507 - fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 360507 - fluvastatin 80 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Fluvastatin Sodium
Non-Proprietary Name
Fluvastatin Sodium
Substance Name
Fluvastatin Sodium
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUVASTATIN SODIUM 80 mg/1
Pharmacologic Class
Usage Information
Fluvastatin 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
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA079011
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2016
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 (0093-7446). Click a package code to view its specific billing and regulatory data.

0093-7446-56
30 TABLET, FILM COATED, EXTENDED RELEASE 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 0093-7446-01 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Fluvastatin Sodium, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This tablet, film coated, extended release is formulated for oral use and contains fluvastatin sodium 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 Teva Pharmaceuticals Usa, Inc. on June 02, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Fluvastatin 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 Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093744601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0093-7446-01
11-Digit CMS (5-4-2)
00093-7446-01

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