Methylphenidate Hydrochloride Tablet, Chewable
NDC Package 43386-571-01

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

Package Information

Methylphenidate Hydrochloride tablets is attention Deficit Disorders, NarcolepsyAttention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). This formulation utilizes a tablet, chewable delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-571 and is authorized under FDA application ANDA204115.

Identification & Billing

NDC Package Code
43386-571-01
Package Description
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code
43386-571
11-Digit Billing Format
43386057101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204115
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-2015
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 43386-571-01 identifies a specific commercial package of 100 tablet, chewable in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This tablet, chewable is formulated for oral use and contains methylphenidate hydrochloride 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 Lupin Pharmaceuticals,inc. on April 06, 2015. The current certification is valid through December 31, 2026.

How is this Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386057101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
43386-571-01
11-Digit CMS (5-4-2)
43386-0571-01

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