Dextroamphetamine Sulfate
NDC Package 76181-002-25

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.

Dextroamphetamine Sulfate is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Avadel Generics, Llc, this product is identified by NDC 76181-002 and is authorized under FDA application ANDA040776.

Identification & Billing

NDC Package Code
76181-002-25
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
76181-002
11-Digit Billing Format
76181000225
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

Clinical Specifications

Proprietary Name
Dextroamphetamine Sulfate
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. Dextroamphetamine 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. This medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

Regulatory & Marketing

Labeler Name
Avadel Generics, Llc
FDA Application #
ANDA040776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2014
End Marketing Date
09-30-2020
Listing Expiration
09-30-2020
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 76181-002-25 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Dextroamphetamine Sulfate, labeled by Avadel Generics, Llc. 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 Avadel Generics, Llc on January 06, 2014. The current certification is valid through September 30, 2020.

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. Dextroamphetamine 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. This medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

How is this Avadel Generics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76181000225. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
76181-002-25
11-Digit CMS (5-4-2)
76181-0002-25

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