Nadolol Tablet
NDC Package 76282-348-01

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

Package Information

Nadolol tablets is nadolol is used alone or with other medications to treat high blood pressure (hypertension) and to prevent chest pain (angina). This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-348 and is authorized under FDA application ANDA203455.

Identification & Billing

NDC Package Code
76282-348-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
76282-348
11-Digit Billing Format
76282034801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nadolol
Non-Proprietary Name
Nadolol
Substance Name
Nadolol
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)
NADOLOL 40 mg/1
Pharmacologic Class
Usage Information
Nadolol is used alone or with other medications to treat high blood pressure (hypertension) and to prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. In the management of chest pain, nadolol may also help to reduce the frequency of chest pain episodes and improve your ability to exercise. Nadolol belongs to a class of medications called beta blockers. It works by blocking the action of certain natural substances such as adrenaline (epinephrine) on the heart and blood vessels. This results in a lowering of heart rate, blood pressure, and strain on the heart.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203455
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-27-2020
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 76282-348-01 identifies a specific commercial package of 100 tablet in 1 bottle of Nadolol, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This tablet is formulated for oral use and contains nadolol 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 July 27, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Nadolol is used alone or with other medications to treat high blood pressure (hypertension) and to prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. In the management of chest pain, nadolol may also help to reduce the frequency of chest pain episodes and improve your ability to exercise. Nadolol belongs to a class of medications called beta blockers. It works by blocking the action of certain natural substances such as adrenaline (epinephrine) on the heart and blood vessels. This results in a lowering of heart rate, blood pressure, and strain on the heart.

How is this Exelan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282034801. 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)
76282-348-01
11-Digit CMS (5-4-2)
76282-0348-01

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