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  5. NDC Package Code: 80491-0812-8 Tryvio

NDC Package 80491-0812-8 Tryvio

Aprocitentan Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80491-0812-8
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-0812-7)
Product Code:
80491-0812
Proprietary Name:
Tryvio
Non-Proprietary Name:
Aprocitentan
Substance Name:
Aprocitentan
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.
11-Digit NDC Billing Format:
80491081208
NDC to RxNorm Crosswalk:
  • RxCUI: 2679064 - aprocitentan 12.5 MG Oral Tablet
  • RxCUI: 2679070 - TRYVIO 12.5 MG Oral Tablet
  • RxCUI: 2679070 - aprocitentan 12.5 MG Oral Tablet [Tryvio]
  • RxCUI: 2679070 - Tryvio 12.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Idorsia Pharmaceuticals Ltd
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • APROCITENTAN 12.5 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA217686
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-20-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    80491-0812-31 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80491-0812-8?

    The NDC Packaged Code 80491-0812-8 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (80491-0812-7) of Tryvio, a human prescription drug labeled by Idorsia Pharmaceuticals Ltd. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 80491-0812 included in the NDC Directory?

    Yes, Tryvio with product code 80491-0812 is active and included in the NDC Directory. The product was first marketed by Idorsia Pharmaceuticals Ltd on March 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80491-0812-8?

    The 11-digit format is 80491081208. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-180491-0812-85-4-280491-0812-08