Corlanor Tablet, Film Coated
NDC Package 55513-810-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Corlanor (ivabradine) tablets is a medication used to treat heart failure. This formulation utilizes a tablet, film coated delivery system. Marketed by Amgen Inc, this product is identified by NDC 55513-810 and is authorized under FDA application NDA206143.

Identification & Billing

NDC Package Code
55513-810-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
55513-810
11-Digit Billing Format
55513081060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Corlanor
Non-Proprietary Name
Ivabradine
Substance Name
Ivabradine Hydrochloride
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)
IVABRADINE HYDROCHLORIDE 7.5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat heart failure. It is used by adults to help prevent the heart failure from getting worse and needing treatment in a hospital. It is also used by children who have heart failure due to an enlarged heart (dilated cardiomyopathy). Heart failure is a condition where your heart does not pump blood as well as it should. Ivabradine works by making your heart beat more slowly.

Regulatory & Marketing

Labeler Name
Amgen Inc
Product Type
Human Prescription Drug
FDA Application #
NDA206143
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-20-2015
Listing Expiration
12-31-2026
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 55513-810-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Corlanor, a human prescription drug labeled by Amgen Inc. This tablet, film coated is formulated for oral use and contains ivabradine hydrochloride 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 Amgen Inc on April 20, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat heart failure. It is used by adults to help prevent the heart failure from getting worse and needing treatment in a hospital. It is also used by children who have heart failure due to an enlarged heart (dilated cardiomyopathy). Heart failure is a condition where your heart does not pump blood as well as it should. Ivabradine works by making your heart beat more slowly.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513081060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
55513-810-60
11-Digit CMS (5-4-2)
55513-0810-60

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