Ranolazine Tablet, Film Coated, Extended Release
NDC Package 69367-293-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, film coated, extended release delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-293 and is authorized under FDA application ANDA211829.

Identification & Billing

NDC Package Code
69367-293-60
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
69367-293
11-Digit Billing Format
69367029360
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
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, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
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
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211829
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-24-2021
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 69367-293-60 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle of Ranolazine, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This tablet, film coated, 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 Westminster Pharmaceuticals, Llc on August 24, 2021. 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 Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367029360. 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)
69367-293-60
11-Digit CMS (5-4-2)
69367-0293-60

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