Adderall
NDC Package 54868-4640-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Adderall is this combination medication is used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4640 and is authorized under FDA application NDA021303.

Identification & Billing

NDC Package Code
54868-4640-2
Package Description
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
54868-4640
11-Digit Billing Format
54868464002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 861221 - dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861221 - 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule
  • RxCUI: 861221 - amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 861222 - ADDERALL XR 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861222 - 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule [Adderall]

Clinical Specifications

Proprietary Name
Adderall XR
Dosage Form
-
Usage Information
This combination medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine/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 drug 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
Physicians Total Care, Inc.
FDA Application #
NDA021303
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4640). Click a package code to view its specific billing and regulatory data.

54868-4640-0
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
54868-4640-1
10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* 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 54868-4640-2 identifies a specific commercial package of 60 capsule, extended release in 1 bottle of Adderall XR, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Physicians Total Care, Inc. on March 01, 2005. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This combination medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine/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 drug 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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868464002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-4-1)
54868-4640-2
11-Digit CMS (5-4-2)
54868-4640-02

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