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  5. NDC Package Code: 80491-7825-3 Quviviq

NDC Package 80491-7825-3 Quviviq

Daridorexant 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:
80491-7825-3
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
80491-7825
Proprietary Name:
Quviviq
Non-Proprietary Name:
Daridorexant
Substance Name:
Daridorexant
Usage Information:
QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].
11-Digit NDC Billing Format:
80491782503
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2591502 - daridorexant 25 MG Oral Tablet
  • RxCUI: 2591502 - daridorexant 25 MG (as daridorexant hydrochloride 27 MG) Oral Tablet
  • RxCUI: 2591508 - QUVIVIQ 25 MG Oral Tablet
  • RxCUI: 2591508 - daridorexant 25 MG Oral Tablet [Quviviq]
  • RxCUI: 2591508 - Quviviq 25 MG (equivalent to daridorexant hydrochloride 27 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):
  • DARIDOREXANT 25 mg/1
    • Pharmacologic Class(es):
  • Orexin Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Orexin Receptor Antagonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA214985
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-07-2022
    Listing Expiration Date:
    12-31-2024
    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
    80491-7825-21 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80491-7825-3?

    The NDC Packaged Code 80491-7825-3 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Quviviq, 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 80491-7825 included in the NDC Directory?

    Yes, Quviviq with product code 80491-7825 is active and included in the NDC Directory. The product was first marketed by Idorsia Pharmaceuticals Ltd on April 07, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 80491-7825-3?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 80491-7825-3?

    The 11-digit format is 80491782503. 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
    5-4-180491-7825-35-4-280491-7825-03