Amlodipine Besylate Powder
NDC Package 65841-014-06

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

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.

Amlodipine Besylate powders is amlodipine is used with or without other medications to treat high blood pressure. This formulation utilizes a powder delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-014.

Identification & Billing

NDC Package Code
65841-014-06
Package Description
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 10 kg in 1 BAG
Product Code
65841-014
11-Digit Billing Format
65841001406

Clinical Specifications

Proprietary Name
Amlodipine Besylate
Non-Proprietary Name
Amlodipine Besylate
Substance Name
Amlodipine Besylate
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)
AMLODIPINE BESYLATE 1 kg/kg
Usage Information
Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.

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
09-16-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65841-014). Click a package code to view its specific billing and regulatory data.

65841-014-01
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / .4 kg in 1 BAG
65841-014-02
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 1 kg in 1 BAG
65841-014-03
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 2 kg in 1 BAG
65841-014-05
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 5 kg in 1 BAG
65841-014-10
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 20 kg in 1 BAG

* 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 65841-014-06 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 Amlodipine Besylate (UNFINISHED drug), a bulk ingredient labeled by Zydus Lifesciences Limited. This powder is formulated for use and contains amlodipine besylate 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 September 16, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841001406. 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)
65841-014-06
11-Digit CMS (5-4-2)
65841-0014-06

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