Ranolazine Tablet, Extended Release
NDC Package 63304-017-28

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

Ranolazine tablets is ranolazine is used to treat a certain type of chest pain (chronic stable angina). This formulation utilizes a tablet, extended release delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 63304-017 and is authorized under FDA application ANDA211707.

Identification & Billing

NDC Package Code
63304-017-28
Package Description
180 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
63304-017
11-Digit Billing Format
63304001728
RxNorm Crosswalk
  • RxCUI: 616749 - ranolazine 500 MG 12HR Extended Release Oral Tablet
  • RxCUI: 616749 - 12 HR ranolazine 500 MG Extended Release Oral Tablet
  • RxCUI: 616749 - ranolazine 500 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 728231 - ranolazine 1000 MG 12HR Extended Release Oral Tablet
  • RxCUI: 728231 - 12 HR ranolazine 1000 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Ranolazine
Non-Proprietary Name
Ranolazine
Substance Name
Ranolazine
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RANOLAZINE 500 mg/1
Pharmacologic Class
Usage Information
Ranolazine is used to treat a certain type of chest pain (chronic stable angina). It decreases the number of times you may get chest pain. Relieving symptoms of angina can increase your ability to exercise and perform strenuous work. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (including nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol). It is thought to work by improving how well the heart uses oxygen so that it can do more work with less oxygen.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211707
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2019
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 (63304-017). Click a package code to view its specific billing and regulatory data.

63304-017-05
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
63304-017-60
60 TABLET, EXTENDED RELEASE 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 63304-017-28 identifies a specific commercial package of 180 tablet, extended release in 1 bottle of Ranolazine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, extended release is formulated for oral use and contains ranolazine 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 Sun Pharmaceutical Industries, Inc. on May 28, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ranolazine is used to treat a certain type of chest pain (chronic stable angina). It decreases the number of times you may get chest pain. Relieving symptoms of angina can increase your ability to exercise and perform strenuous work. Ranolazine works differently than other drugs for angina, so it can be used with your other angina medications (including nitrates, calcium channel blockers such as amlodipine, beta blockers such as metoprolol). It is thought to work by improving how well the heart uses oxygen so that it can do more work with less oxygen.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304001728. 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)
63304-017-28
11-Digit CMS (5-4-2)
63304-0017-28

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