NDC Package 54868-5683-0 Focalinxr

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54868-5683-0
Package Description:
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Focalinxr
Usage Information:
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies (14)].A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.Special Diagnostic ConsiderationsSpecific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics. Need for Comprehensive Treatment ProgramFocalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.Long-Term UseThe effectiveness of Focalin XR for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Focalin XR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
11-Digit NDC Billing Format:
54868568300
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 899439 - dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899439 - 24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule
  • RxCUI: 899439 - dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 899441 - Focalin XR 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899441 - 24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Focalin]
  • Labeler Name:
    Physicians Total Care, Inc.
    Sample Package:
    No
    Start Marketing Date:
    10-11-2006
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    54868-5683-110 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54868-5683-0?

    The NDC Packaged Code 54868-5683-0 is assigned to a package of 30 capsule, extended release in 1 bottle, plastic of Focalinxr, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 54868-5683 included in the NDC Directory?

    No, Focalinxr with product code 54868-5683 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on October 11, 2006 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54868-5683-0?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 54868-5683-0?

    The 11-digit format is 54868568300. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-154868-5683-05-4-254868-5683-00