Nitroglycerin
NDC Package 47781-458-01

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.

Nitroglycerin is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). Marketed by Alvogen Inc., this product is identified by NDC 47781-458 and is authorized under FDA application ANDA211604.

Identification & Billing

NDC Package Code
47781-458-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
47781-458
11-Digit Billing Format
47781045801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Nitroglycerin
Dosage Form
-
Usage Information
This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

Regulatory & Marketing

Labeler Name
Alvogen Inc.
FDA Application #
ANDA211604
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2019
End Marketing Date
06-01-2024
Listing Expiration
06-01-2024
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 47781-458-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Nitroglycerin, labeled by Alvogen Inc.. 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 Alvogen Inc. on April 30, 2019. The current certification is valid through June 01, 2024.

What are the primary indications for this medication?

This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

How is this Alvogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781045801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
47781-458-01
11-Digit CMS (5-4-2)
47781-0458-01

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