Nitroglycerin Lingual Spray
NDC Package 45802-210-01

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

Nitroglycerin Lingual (nitroglycerin) sprays is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). This formulation utilizes a spray delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-210 and is authorized under FDA application ANDA091496.

Identification & Billing

NDC Package Code
45802-210-01
Package Description
1 BOTTLE in 1 CARTON / 60 SPRAY in 1 BOTTLE
Product Code
45802-210
11-Digit Billing Format
45802021001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitroglycerin Lingual
Non-Proprietary Name
Nitroglycerin
Substance Name
Nitroglycerin
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NITROGLYCERIN 400 ug/1
Pharmacologic Class
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA091496
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-20-2013
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 (45802-210). Click a package code to view its specific billing and regulatory data.

45802-210-02
1 BOTTLE in 1 CARTON / 200 SPRAY 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 45802-210-01 identifies a specific commercial package of 1 bottle in 1 carton / 60 spray in 1 bottle of Nitroglycerin Lingual, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This spray is formulated for oral use and contains nitroglycerin 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 Padagis Israel Pharmaceuticals Ltd on September 20, 2013. The current certification is valid through December 31, 2026.

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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802021001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
45802-210-01
11-Digit CMS (5-4-2)
45802-0210-01

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