Atorvastatin Calcium Tablet, Film Coated
NDC Package 76420-943-30

11-digit billing NDC: 76420094330
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Atorvastatin Calcium tablets is atorvastatin calcium is indicated:To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHDAs an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.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:Primary dysbetalipoproteinemiaHypertriglyceridemia. This formulation utilizes a tablet, film coated delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-943 and is authorized under FDA application ANDA209288.

Identification & Billing

NDC Package Code
76420-943-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
76420-943
11-Digit Billing Format
76420094330
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 10 mg/1
Pharmacologic Class
Usage Information
Atorvastatin calcium is indicated:To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHDAs an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.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:Primary dysbetalipoproteinemiaHypertriglyceridemia

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209288
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76420-943). Click a package code to view its specific billing and regulatory data.

76420-943-00
1000 TABLET, FILM COATED in 1 BOTTLE
76420-943-05
500 TABLET, FILM COATED in 1 BOTTLE
76420-943-12
120 TABLET, FILM COATED in 1 BOTTLE
76420-943-20
20 TABLET, FILM COATED in 1 BOTTLE
76420-943-38
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
76420-943-55
5000 TABLET, FILM COATED in 1 BOTTLE
76420-943-60
60 TABLET, FILM COATED in 1 BOTTLE
76420-943-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 76420-943-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Atorvastatin Calcium, a human prescription drug labeled by Asclemed Usa, 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 Asclemed Usa, Inc. on December 23, 2018. The current certification is valid through December 31, 2027.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420094330. 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)
76420-943-30
11-Digit CMS (5-4-2)
76420-0943-30

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