Atorvastatin Calcium
NDC Package 72134-010-01

11-digit billing NDC: 72134001001
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Atorvastatin Calcium is therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Marketed by Agnitio Inc., this product is identified by NDC 72134-010 and is authorized under FDA application ANDA214969.

Identification & Billing

NDC Package Code
72134-010-01
Package Description
30 TABLET in 1 BOTTLE
Product Code
72134-010
11-Digit Billing Format
72134001001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atorvastatin Calcium
Dosage Form
-
Usage Information
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.

Regulatory & Marketing

Labeler Name
Agnitio Inc.
FDA Application #
ANDA214969
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 (72134-010). Click a package code to view its specific billing and regulatory data.

72134-010-02
90 TABLET in 1 BOTTLE
72134-010-03
500 TABLET in 1 BOTTLE
72134-010-04
1000 TABLET 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 72134-010-01 identifies a specific commercial package of 30 tablet in 1 bottle of Atorvastatin Calcium, labeled by Agnitio Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Agnitio Inc. on September 30, 2022. The current certification is valid through December 31, 2023.

How is this Agnitio Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72134001001. 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)
72134-010-01
11-Digit CMS (5-4-2)
72134-0010-01

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