Nitrostat Tablet
NDC Package 58151-310-01

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

Nitrostat (nitroglycerin) tablets is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). This formulation utilizes a tablet delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 58151-310 and is authorized under FDA application NDA021134.

Identification & Billing

NDC Package Code
58151-310-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
58151-310
11-Digit Billing Format
58151031001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitrostat
Non-Proprietary Name
Nitroglycerin
Substance Name
Nitroglycerin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
NITROGLYCERIN .4 mg/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
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021134
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-02-2024
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 (58151-310). Click a package code to view its specific billing and regulatory data.

58151-310-52
4 BOTTLE in 1 CARTON / 25 TABLET in 1 BOTTLE (58151-310-94)

* 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 58151-310-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Nitrostat, a human prescription drug labeled by Viatris Specialty Llc. This tablet is formulated for sublingual 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 Viatris Specialty Llc on February 02, 2024. 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 Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58151031001. 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)
58151-310-01
11-Digit CMS (5-4-2)
58151-0310-01

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