Dyanavel Xr
NDC Package 27808-102-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Dyanavel Xr is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Tris Pharma Inc, this product is identified by NDC 27808-102 and is authorized under FDA application NDA208147.

Identification & Billing

NDC Package Code
27808-102-01
Package Description
464 mL in 1 BOTTLE
Product Code
27808-102
11-Digit Billing Format
27808010201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
464 ML

Clinical Specifications

Proprietary Name
Dyanavel Xr
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Tris Pharma Inc
FDA Application #
NDA208147
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2015
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
Exclude Flag
D
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 27808-102-01 identifies a specific commercial package of 464 ml in 1 bottle of Dyanavel Xr, labeled by Tris Pharma Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Tris Pharma Inc on October 01, 2015. The current certification is valid through December 31, 2023.

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 Tris Pharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27808010201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 464 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)
27808-102-01
11-Digit CMS (5-4-2)
27808-0102-01

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