Amlodipine Besylate
NDC Package 55154-4331-0

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Amlodipine Besylate is amlodipine is used with or without other medications to treat high blood pressure. Marketed by Cardinal Health, this product is identified by NDC 55154-4331 and is authorized under FDA application ANDA078552.

Identification & Billing

NDC Package Code
55154-4331-0
Package Description
10 BLISTER PACK in 1 BAG / 1 TABLET in 1 BLISTER PACK
Product Code
55154-4331
11-Digit Billing Format
55154433100

Clinical Specifications

Proprietary Name
Amlodipine Besylate
Dosage Form
-
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
Cardinal Health
FDA Application #
ANDA078552
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-10-2014
End Marketing Date
11-30-2020
Listing Expiration
11-30-2020
Exclude Flag
D
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 55154-4331-0 identifies a specific commercial package of 10 blister pack in 1 bag / 1 tablet in 1 blister pack of Amlodipine Besylate, labeled by Cardinal Health. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Cardinal Health on January 10, 2014. The current certification is valid through November 30, 2020.

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 Cardinal Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154433100. 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 (5-4-1)
55154-4331-0
11-Digit CMS (5-4-2)
55154-4331-00

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