Adzenys Xr-odt Tablet, Orally Disintegrating
NDC Package 70165-005-30

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

Package Information

Adzenys Xr-odt (amphetamine) tablets is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Neos Therapeutics Brands, Llc, this product is identified by NDC 70165-005 and is authorized under FDA application NDA204326.

Identification & Billing

NDC Package Code
70165-005-30
Package Description
30 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
70165-005
11-Digit Billing Format
70165000530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1739803 - amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
  • RxCUI: 1739803 - 24 HR amphetamine 12.5 MG Extended Release Oral Tablet
  • RxCUI: 1739803 - amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet
  • RxCUI: 1739809 - Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
  • RxCUI: 1739809 - 24 HR amphetamine 12.5 MG Extended Release Oral Tablet [Adzenys]

Clinical Specifications

Proprietary Name
Adzenys Xr-odt
Non-Proprietary Name
Amphetamine
Substance Name
Amphetamine
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMPHETAMINE 3.1 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Neos Therapeutics Brands, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204326
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-16-2016
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 70165-005-30 identifies a specific commercial package of 30 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack of Adzenys Xr-odt, a human prescription drug labeled by Neos Therapeutics Brands, Llc. This tablet, orally disintegrating is formulated for oral use and contains amphetamine 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 Neos Therapeutics Brands, Llc on February 16, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70165000530. 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 (5-3-2)
70165-005-30
11-Digit CMS (5-4-2)
70165-0005-30

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