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  5. NDC Package Code: 24478-108-01 Dyanavel Xr

NDC Package 24478-108-01 Dyanavel Xr

Amphetamine Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
24478-108-01
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
24478-108
Proprietary Name:
Dyanavel Xr
Non-Proprietary Name:
Amphetamine
Substance Name:
Amphetamine
Usage Information:
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
11-Digit NDC Billing Format:
24478010801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1720586 - amphetamine 2.5 MG in 1 mL 24HR Extended Release Suspension
  • RxCUI: 1720586 - 24 HR amphetamine 2.5 MG/ML Extended Release Suspension
  • RxCUI: 1720586 - amphetamine 2.5 MG per 1 ML 24 HR Extended Release Suspension
  • RxCUI: 1720586 - amphetamine 2.5 MG/ML 24 HR Extended Release Suspension
  • RxCUI: 1720592 - Dyanavel XR 2.5 MG in 1 mL 24HR Extended Release Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Nextwave Pharmaceuticals, Inc
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMPHETAMINE 10 mg/1
    • Pharmacologic Class(es):
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA210526
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-04-2021
    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.

    Frequently Asked Questions

    What is NDC 24478-108-01?

    The NDC Packaged Code 24478-108-01 is assigned to a package of 30 tablet, extended release in 1 bottle of Dyanavel Xr, a human prescription drug labeled by Nextwave Pharmaceuticals, Inc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 24478-108 included in the NDC Directory?

    Yes, Dyanavel Xr with product code 24478-108 is active and included in the NDC Directory. The product was first marketed by Nextwave Pharmaceuticals, Inc on November 04, 2021 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 24478-108-01?

    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 30.

    What is the 11-digit format for NDC 24478-108-01?

    The 11-digit format is 24478010801. 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 5-3-2 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
    5-3-224478-108-015-4-224478-0108-01