NDC Package 54868-3454-6 Methylphenidate Hydrochloride

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:
54868-3454-6
Package Description:
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Methylphenidate Hydrochloride
Usage Information:
Attention Deficit Disorders, NarcolepsyAttention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional 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.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.Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. 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 one or more of these characteristics.Drug treatment is not 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 primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. 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.
11-Digit NDC Billing Format:
54868345406
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1091225 - methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091225 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1091225 - methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet
  • Labeler Name:
    Physicians Total Care, Inc.
    Sample Package:
    No
    Start Marketing Date:
    12-16-1994
    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
    54868-3454-050 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    54868-3454-160 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    54868-3454-220 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    54868-3454-3100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    54868-3454-430 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    54868-3454-510 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54868-3454-6?

    The NDC Packaged Code 54868-3454-6 is assigned to a package of 90 tablet, extended release in 1 bottle, plastic of Methylphenidate Hydrochloride, 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 90 billable units per package.

    Is NDC 54868-3454 included in the NDC Directory?

    No, Methylphenidate Hydrochloride with product code 54868-3454 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 December 16, 1994 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 54868-3454-6?

    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 90.

    What is the 11-digit format for NDC 54868-3454-6?

    The 11-digit format is 54868345406. 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
    5-4-154868-3454-65-4-254868-3454-06