Tryvio Tablet, Film Coated
NDC Package 80491-8012-3

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

Tryvio (aprocitentan) tablets is tRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. This formulation utilizes a tablet, film coated delivery system. Marketed by Idorsia Pharmaceuticals Ltd, this product is identified by NDC 80491-8012 and is authorized under FDA application NDA217686.

Identification & Billing

NDC Package Code
80491-8012-3
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
80491-8012
11-Digit Billing Format
80491801203
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
Tryvio
Non-Proprietary Name
Aprocitentan
Substance Name
Aprocitentan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
APROCITENTAN 12.5 mg/1
Pharmacologic Class
Usage Information
TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO.Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve BP goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is BP reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher BPs, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from BP 2 reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower BP goal.

Regulatory & Marketing

Labeler Name
Idorsia Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA217686
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-20-2024
Listing Expiration
12-31-2027
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 (80491-8012). Click a package code to view its specific billing and regulatory data.

80491-8012-8
1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)

* 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 80491-8012-3 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Tryvio, a human prescription drug labeled by Idorsia Pharmaceuticals Ltd. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains aprocitentan 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 Idorsia Pharmaceuticals Ltd on March 20, 2024. The current certification is valid through December 31, 2027.

How is this Idorsia Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80491801203. 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 (5-4-1)
80491-8012-3
11-Digit CMS (5-4-2)
80491-8012-03

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