Atorvastatin Calcium Tablet, Film Coated
NDC Package 68071-5344-3

11-digit billing NDC: 68071534403
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Atorvastatin Calcium tablets is   are indicated:  • To reduce the risk of:  o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with      multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD  o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD  but without clinically evident CHD  o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for       congestive heart failure, and angina in adults with clinically evident CHD  • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:  o Adults with primary hyperlipidemia.  o Adults and pediatric patients aged 10 years and older with heterozygous familial      hypercholesterolemia (HeFH).  • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  • As an adjunct to diet for the treatment of adults with:  o Primary dysbetalipoproteinemia  o Hypertriglyceridemia. This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-5344 and is authorized under FDA application ANDA214344.

Identification & Billing

NDC Package Code
68071-5344-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-5344
11-Digit Billing Format
68071534403

Clinical Specifications

Proprietary Name
Atorvastatin Calcium
Non-Proprietary Name
Atorvastatin Calcium
Substance Name
Atorvastatin Calcium Trihydrate
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)
ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1
Pharmacologic Class
Usage Information
Atorvastatin calcium tablets  are indicated:  • To reduce the risk of:  o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with      multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD  o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD  but without clinically evident CHD  o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for       congestive heart failure, and angina in adults with clinically evident CHD  • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:  o Adults with primary hyperlipidemia.  o Adults and pediatric patients aged 10 years and older with heterozygous familial      hypercholesterolemia (HeFH).  • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  • As an adjunct to diet for the treatment of adults with:  o Primary dysbetalipoproteinemia  o Hypertriglyceridemia

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214344
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2024
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 68071-5344-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Atorvastatin Calcium, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains atorvastatin calcium trihydrate 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 October 01, 2024. 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: 68071534403. 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)
68071-5344-3
11-Digit CMS (5-4-2)
68071-5344-03

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