Rosuvastatin Calcium Tablet
NDC Package 68071-5333-9

11-digit billing NDC: 68071533309
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rosuvastatin Calcium tablets is rosuvastatin tablet is an HMG Co-A reductase inhibitor (statin) indicated: ( 1) 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 primary 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. This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-5333 and is authorized under FDA application ANDA207626.

Identification & Billing

NDC Package Code
68071-5333-9
Package Description
90 TABLET in 1 BOTTLE
Product Code
68071-5333
11-Digit Billing Format
68071533309

Clinical Specifications

Proprietary Name
Rosuvastatin Calcium
Non-Proprietary Name
Rosuvastatin Calcium
Substance Name
Rosuvastatin Calcium
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROSUVASTATIN CALCIUM 10 mg/1
Pharmacologic Class
Usage Information
Rosuvastatin tablet is an HMG Co-A reductase inhibitor (statin) indicated: ( 1) 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 primary 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
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207626
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2025
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 68071-5333-9 identifies a specific commercial package of 90 tablet in 1 bottle of Rosuvastatin Calcium, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet 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 Nucare Pharmaceuticals, Inc. on December 15, 2025. The current certification is valid through December 31, 2027.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071533309. 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)
68071-5333-9
11-Digit CMS (5-4-2)
68071-5333-09

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