Atorvastatin Calcium Tablet, Film Coated
NDC Package 82009-178-10

11-digit billing NDC: 82009017810 · Billing unit: EA · 1000 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Quallent Pharmaceuticals Health Llc, this product is identified by NDC 82009-178 and is authorized under FDA application ANDA214344.

Identification & Billing

NDC Package Code
82009-178-10
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
82009-178
11-Digit Billing Format
82009017810
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

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 40 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
Quallent Pharmaceuticals Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214344
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2025
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 82009-178-10 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Atorvastatin Calcium, a human prescription drug labeled by Quallent Pharmaceuticals Health Llc. 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 Quallent Pharmaceuticals Health Llc on August 01, 2025. The current certification is valid through December 31, 2027.

How is this Quallent Pharmaceuticals Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82009017810. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
82009-178-10
11-Digit CMS (5-4-2)
82009-0178-10

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