Gonitro
NDC Package 28595-705-36

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Gonitro is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). Marketed by Allegis Pharmaceuticals, Inc., this product is identified by NDC 28595-705 and is authorized under FDA application NDA208424.

Identification & Billing

NDC Package Code
28595-705-36
Package Description
36 PACKET in 1 BOX / 1 POWDER in 1 PACKET
Product Code
11-Digit Billing Format
28595070536
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
36 EA

Clinical Specifications

Proprietary Name
Gonitro
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
Allegis Pharmaceuticals, Inc.
FDA Application #
NDA208424
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2019
End Marketing Date
06-30-2023
Listing Expiration
06-30-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (28595-705). Click a package code to view its specific billing and regulatory data.

12 PACKET in 1 BOX / 1 POWDER in 1 PACKET (28595-705-01)
96 PACKET in 1 BOX / 1 POWDER in 1 PACKET
3 PACKET in 1 BOX / 1 POWDER in 1 PACKET

* 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 28595-705-36 identifies a specific commercial package of 36 packet in 1 box / 1 powder in 1 packet of Gonitro, labeled by Allegis Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 36 billable units per package. 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 Allegis Pharmaceuticals, Inc. on July 01, 2019. The current certification is valid through June 30, 2023.

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 Allegis Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 28595070536. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 36 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)
28595-705-36
11-Digit CMS (5-4-2)
28595-0705-36

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