Ranolazine Powder
NDC Package 65841-034-02

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ranolazine powders is ranolazine is used to treat a certain type of chest pain (chronic stable angina). This formulation utilizes a powder delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-034.

Identification & Billing

NDC Package Code
65841-034-02
Package Description
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 10 kg in 1 BAG
Product Code
65841-034
11-Digit Billing Format
65841003402

Clinical Specifications

Proprietary Name
Ranolazine
Non-Proprietary Name
Ranolazine
Substance Name
Ranolazine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
RANOLAZINE 10 kg/10kg
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
Zydus Lifesciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-28-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65841-034-02 identifies a specific commercial package of 1 pouch in 1 drum / 1 bag in 1 pouch / 1 bag in 1 bag / 10 kg in 1 bag of Ranolazine (UNFINISHED drug), a bulk ingredient labeled by Zydus Lifesciences Limited. This powder is formulated for 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 Zydus Lifesciences Limited on January 28, 2020. 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 Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841003402. 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)
65841-034-02
11-Digit CMS (5-4-2)
65841-0034-02

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