Azstarys Capsule
NDC Package 65038-286-99

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

Package Information

Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules is aZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. This formulation utilizes a capsule delivery system. Marketed by Commave Sub, Llc, this product is identified by NDC 65038-286 and is authorized under FDA application NDA212994.

Identification & Billing

NDC Package Code
65038-286-99
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
65038-286
11-Digit Billing Format
65038028699
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 2562186 - Azstarys 5.2 MG / 26.1 MG Oral Capsule
  • RxCUI: 2562186 - dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule [Azstarys]
  • RxCUI: 2562186 - Azstarys (dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG)) Oral Capsule
  • RxCUI: 2562187 - dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule
  • RxCUI: 2562187 - dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Azstarys
Non-Proprietary Name
Serdexmethylphenidate And Dexmethylphenidate
Substance Name
Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Commave Sub, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA212994
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-16-2021
Listing Expiration
12-31-2027
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 65038-286-99 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Azstarys, a human prescription drug labeled by Commave Sub, Llc. This capsule is formulated for oral use and contains dexmethylphenidate hydrochloride; serdexmethylphenidate chloride 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 Commave Sub, Llc on July 16, 2021. The current certification is valid through December 31, 2027.

How is this Commave Sub, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65038028699. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
65038-286-99
11-Digit CMS (5-4-2)
65038-0286-99

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