1. Home
  2. Labeler Index
  3. Alembic Pharmaceuticals Limited
  4. 46708-679
  5. NDC Package Code: 46708-679-60 Ivabradine

NDC Package 46708-679-60 Ivabradine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
46708-679-60
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
46708-679
Proprietary Name:
Ivabradine
Non-Proprietary Name:
Ivabradine
Substance Name:
Ivabradine Hydrochloride
Usage Information:
Ivabradine tablets are contraindicated in patients with: Acute decompensated heart failure Clinically significant hypotensionSick 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)]
11-Digit NDC Billing Format:
46708067960
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Alembic Pharmaceuticals Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
IVABRADINE HYDROCHLORIDE 5 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA215238
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
12-20-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
46708-679-45180 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 46708-679-60?

The NDC Packaged Code 46708-679-60 is assigned to a package of 60 tablet, film coated in 1 bottle of Ivabradine, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 46708-679 included in the NDC Directory?

Yes, Ivabradine with product code 46708-679 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on December 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 46708-679-60?

The 11-digit format is 46708067960. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-246708-679-605-4-246708-0679-60