Rosuvastatin Calcium
NDC Package 42292-032-20

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Rosuvastatin Calcium is rosuvastatin 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. Marketed by Mylan Institutional Inc., this product is identified by NDC 42292-032 and is authorized under FDA application ANDA079161.

Identification & Billing

NDC Package Code
42292-032-20
Package Description
100 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (42292-032-01)
Product Code
42292-032
11-Digit Billing Format
42292003220
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Rosuvastatin Calcium
Dosage Form
-
Usage Information
Rosuvastatin 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 to 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. Talk with your doctor for more details.

Regulatory & Marketing

Labeler Name
Mylan Institutional Inc.
FDA Application #
ANDA079161
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-16-2016
End Marketing Date
05-31-2019
Listing Expiration
05-31-2019
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42292-032-20 identifies a specific commercial package of 100 box, unit-dose in 1 box, unit-dose / 1 tablet, film coated in 1 box, unit-dose (42292-032-01) of Rosuvastatin Calcium, labeled by Mylan Institutional Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mylan Institutional Inc. on August 16, 2016. The current certification is valid through May 31, 2019.

What are the primary indications for this medication?

Rosuvastatin 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 to 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. Talk with your doctor for more details.

How is this Mylan Institutional Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42292003220. 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 (5-3-2)
42292-032-20
11-Digit CMS (5-4-2)
42292-0032-20

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