Lisdexamfetamine Dimesylate Powder
NDC Package 65392-0118-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lisdexamfetamine Dimesylate powders is lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. This formulation utilizes a powder delivery system. Marketed by Curia New York, Inc., this product is identified by NDC 65392-0118.

Identification & Billing

NDC Package Code
65392-0118-0
Package Description
1 kg in 1 DRUM
Product Code
65392-0118
11-Digit Billing Format
65392011800

Clinical Specifications

Proprietary Name
Lisdexamfetamine Dimesylate
Non-Proprietary Name
Lisdexamfetamine Dimesylate
Substance Name
Lisdexamfetamine Dimesylate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LISDEXAMFETAMINE DIMESYLATE 1 kg/kg
Usage Information
Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting. Lisdexamfetamine may also be used to treat binge eating disorder (BED). It may help to reduce the number of binge eating days. This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use for weight loss due to the risk of serious side effects.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Curia New York, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
02-23-2007
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65392-0118-0 identifies a specific commercial package of 1 kg in 1 drum of Lisdexamfetamine Dimesylate (UNFINISHED drug), a bulk ingredient labeled by Curia New York, Inc.. This powder is formulated for use and contains lisdexamfetamine dimesylate 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 Curia New York, Inc. on February 23, 2007. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting. Lisdexamfetamine may also be used to treat binge eating disorder (BED). It may help to reduce the number of binge eating days. This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use for weight loss due to the risk of serious side effects.

How is this Curia New York, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65392011800. 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)
65392-0118-0
11-Digit CMS (5-4-2)
65392-0118-00

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