Ivabradine Tablet, Film Coated
NDC Package 51407-593-60

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

Package Information

Ivabradine tablets are contraindicated in patients with:Acute decompensated heart failureClinically significant hypotensionSick sinus syndrome, sinoatrial block or 3 rddegree AV block, unless a functioning demand pacemaker is present Clinically significant bradycardia [see Warnings and Precautions (5.3)] Severe hepatic impairment [see Use in Specific Populations (8.6)] Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [see Drug Interactions (7.3)] Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Drug Interactions (7.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Golden State Medical Supply, Inc., this product is identified by NDC 51407-593 and is authorized under FDA application ANDA214051.

Identification & Billing

NDC Package Code
51407-593-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
51407-593
11-Digit Billing Format
51407059360
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
Ivabradine
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
Ivabradine tablets are contraindicated in patients with:Acute decompensated heart failureClinically significant hypotensionSick sinus syndrome, sinoatrial block or 3 rddegree AV block, unless a functioning demand pacemaker is present Clinically significant bradycardia [see Warnings and Precautions (5.3)] Severe hepatic impairment [see Use in Specific Populations (8.6)] Pacemaker dependence (heart rate maintained exclusively by the pacemaker) [see Drug Interactions (7.3)] Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Drug Interactions (7.1)]

Regulatory & Marketing

Labeler Name
Golden State Medical Supply, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214051
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2021
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 51407-593-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Ivabradine, a human prescription drug labeled by Golden State Medical Supply, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Golden State Medical Supply, Inc. on December 30, 2021. The current certification is valid through December 31, 2026.

How is this Golden State Medical Supply, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51407059360. 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)
51407-593-60
11-Digit CMS (5-4-2)
51407-0593-60

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