Ivabradine Tablet, Film Coated
NDC Package 72205-337-18

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

Package Information

Ivabradine tablets is ivabradine is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3rd degree 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 Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-337 and is authorized under FDA application ANDA213483.

Identification & Billing

NDC Package Code
72205-337-18
Package Description
180 TABLET, FILM COATED in 1 BOTTLE
Product Code
72205-337
11-Digit Billing Format
72205033718
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 is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3rd degree 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
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213483
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-28-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72205-337). Click a package code to view its specific billing and regulatory data.

72205-337-60
60 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 72205-337-18 identifies a specific commercial package of 180 tablet, film coated in 1 bottle of Ivabradine, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. 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 Novadoz Pharmaceuticals Llc on April 28, 2025. The current certification is valid through December 31, 2026.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205033718. 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)
72205-337-18
11-Digit CMS (5-4-2)
72205-0337-18

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