Xelstrym Patch, Extended Release
NDC Package 68968-0205-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xelstrym (dextroamphetamine) patches is 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)]. This formulation utilizes a patch, extended release delivery system. Marketed by Noven Therapeutics, Llc, this product is identified by NDC 68968-0205 and is authorized under FDA application NDA215401.

Identification & Billing

NDC Package Code
68968-0205-3
Package Description
30 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1)
Product Code
68968-0205
11-Digit Billing Format
68968020503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xelstrym
Non-Proprietary Name
Dextroamphetamine
Substance Name
Dextroamphetamine
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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
DEXTROAMPHETAMINE 4.5 mg/1
Pharmacologic Class
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)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Noven Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215401
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-15-2023
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68968-0205-3 identifies a specific commercial package of 30 pouch in 1 carton / 1 patch, extended release in 1 pouch (68968-0205-1) of Xelstrym, a human prescription drug labeled by Noven Therapeutics, Llc. This patch, extended release is formulated for transdermal use and contains dextroamphetamine 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 Noven Therapeutics, Llc on May 15, 2023. The current certification is valid through December 31, 2026.

How is this Noven Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68968020503. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
68968-0205-3
11-Digit CMS (5-4-2)
68968-0205-03

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