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  5. NDC Package Code: 68968-0220-3 Xelstrym

NDC Package 68968-0220-3 Xelstrym

Dextroamphetamine Patch, Extended Release Transdermal - 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:
68968-0220-3
Package Description:
30 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0220-1)
Product Code:
68968-0220
Proprietary Name:
Xelstrym
Non-Proprietary Name:
Dextroamphetamine
Substance Name:
Dextroamphetamine
Usage Information:
XELSTRYMTM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and patient patients 6 years and older [see CLINICAL TRIALS (14)].Limitations of UsePediatric patients younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [USE IN SPECIFIC POPULATIONS (8.4)].
11-Digit NDC Billing Format:
68968022003
Billing Unit:
C102835
NDC to RxNorm Crosswalk:
  • RxCUI: 2624701 - dextroamphetamine 13.5 MG in 9 HR Transdermal System
  • RxCUI: 2624701 - 9 HR dextroamphetamine 1.5 MG/HR Transdermal System
  • RxCUI: 2624701 - dextroamphetamine 13.5 MG per 9 HR Transdermal System
  • RxCUI: 2624708 - Xelstrym 13.5 MG in 9 HR Transdermal System
  • RxCUI: 2624708 - 9 HR dextroamphetamine 1.5 MG/HR Transdermal System [Xelstrym]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Noven Therapeutics, Llc
    Dosage Form:
    Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • DEXTROAMPHETAMINE 18 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:
    NDA215401
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-15-2023
    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 68968-0220-3?

    The NDC Packaged Code 68968-0220-3 is assigned to a package of 30 pouch in 1 carton / 1 patch, extended release in 1 pouch (68968-0220-1) of Xelstrym, a human prescription drug labeled by Noven Therapeutics, Llc. The product's dosage form is patch, extended release and is administered via transdermal form.

    Is NDC 68968-0220 included in the NDC Directory?

    Yes, Xelstrym with product code 68968-0220 is active and included in the NDC Directory. The product was first marketed by Noven Therapeutics, Llc on May 15, 2023 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 68968-0220-3?

    The contents of this package are billed C102835

    What is the 11-digit format for NDC 68968-0220-3?

    The 11-digit format is 68968022003. 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
    5-4-168968-0220-35-4-268968-0220-03