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  5. NDC Package Code: 43386-571-01 Methylphenidate Hydrochloride

NDC Package 43386-571-01 Methylphenidate Hydrochloride

Tablet, Chewable Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
43386-571-01
Package Description:
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code:
43386-571
Proprietary Name:
Methylphenidate Hydrochloride
Non-Proprietary Name:
Methylphenidate Hydrochloride
Substance 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 Chewable Tablets are 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.
11-Digit NDC Billing Format:
43386057101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1091152 - methylphenidate HCl 10 MG Chewable Tablet
  • RxCUI: 1091152 - methylphenidate hydrochloride 10 MG Chewable Tablet
  • RxCUI: 1091322 - methylphenidate HCl 5 MG Chewable Tablet
  • RxCUI: 1091322 - methylphenidate hydrochloride 5 MG Chewable Tablet
  • RxCUI: 1091389 - methylphenidate HCl 2.5 MG Chewable Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    Dosage Form:
    Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METHYLPHENIDATE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA204115
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-06-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Frequently Asked Questions

    What is NDC 43386-571-01?

    The NDC Packaged Code 43386-571-01 is assigned to a package of 100 tablet, chewable in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is tablet, chewable and is administered via oral form.

    Is NDC 43386-571 included in the NDC Directory?

    Yes, Methylphenidate Hydrochloride with product code 43386-571 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on April 06, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43386-571-01?

    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 100.

    What is the 11-digit format for NDC 43386-571-01?

    The 11-digit format is 43386057101. 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 5-3-2 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
    5-3-243386-571-015-4-243386-0571-01