Amlodipine Besylate Tablet
NDC Package 76282-237-10

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

Amlodipine Besylate tablets is amlodipine is used with or without other medications to treat high blood pressure. This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-237 and is authorized under FDA application ANDA077955.

Identification & Billing

NDC Package Code
76282-237-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
76282-237
11-Digit Billing Format
76282023710
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amlodipine Besylate
Non-Proprietary Name
Amlodipine Besylate
Substance Name
Amlodipine Besylate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMLODIPINE BESYLATE 2.5 mg/1
Pharmacologic Class
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
Exelan Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2007
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 (76282-237). Click a package code to view its specific billing and regulatory data.

76282-237-05
500 TABLET in 1 BOTTLE
76282-237-90
90 TABLET 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 76282-237-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Amlodipine Besylate, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet is formulated for oral 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 Exelan Pharmaceuticals, Inc. on November 02, 2007. 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 Exelan Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282023710. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 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)
76282-237-10
11-Digit CMS (5-4-2)
76282-0237-10

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