Dextroamphetamine Sulfate Solution
NDC Package 66993-359-57

11-digit billing NDC: 66993035957 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dextroamphetamine Sulfate solution is dextroamphetamine Sulfate Oral Solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. This formulation utilizes a solution delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-359 and is authorized under FDA application ANDA040776.

Identification & Billing

NDC Package Code
66993-359-57
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
66993-359
11-Digit Billing Format
66993035957
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 884522 - dextroamphetamine sulfate 5 MG in 5 mL Oral Solution
  • RxCUI: 884522 - dextroamphetamine sulfate 1 MG/ML Oral Solution
  • RxCUI: 884522 - dextroamphetamine sulfate 5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Dextroamphetamine Sulfate
Non-Proprietary Name
Dextroamphetamine Sulfate
Substance Name
Dextroamphetamine Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXTROAMPHETAMINE SULFATE 5 mg/5mL
Pharmacologic Class
Usage Information
Dextroamphetamine Sulfate Oral Solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. 
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
ANDA040776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-15-2014
Listing Expiration
12-31-2026
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 66993-359-57 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Dextroamphetamine Sulfate, a human prescription drug labeled by Prasco Laboratories. This solution is formulated for oral use and contains dextroamphetamine sulfate 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 Prasco Laboratories on May 15, 2014. The current certification is valid through December 31, 2026.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993035957. 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)
66993-359-57
11-Digit CMS (5-4-2)
66993-0359-57

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