Rosuvastatin Calcium Tablet, Film Coated
NDC Package 71209-045-04

11-digit billing NDC: 71209004504
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rosuvastatin Calcium tablets is rosuvastatin tablets are indicated:To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. This formulation utilizes a tablet, film coated delivery system. Marketed by Cadila Pharmaceuticals Limited, this product is identified by NDC 71209-045 and is authorized under FDA application ANDA207453.

Identification & Billing

NDC Package Code
71209-045-04
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
71209-045
11-Digit Billing Format
71209004504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rosuvastatin Calcium
Non-Proprietary Name
Rosuvastatin Calcium
Substance Name
Rosuvastatin Calcium
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)
ROSUVASTATIN CALCIUM 20 mg/1
Pharmacologic Class
Usage Information
Rosuvastatin tablets are indicated:To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events.  As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

Regulatory & Marketing

Labeler Name
Cadila Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2017
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71209-045-04 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Rosuvastatin Calcium, a human prescription drug labeled by Cadila Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains rosuvastatin calcium 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 Cadila Pharmaceuticals Limited on March 24, 2017. The current certification is valid through December 31, 2027.

How is this Cadila Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71209004504. 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)
71209-045-04
11-Digit CMS (5-4-2)
71209-0045-04

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