Dexmethylphenidate Hydrochloride Tablet
NDC Package 55466-122-12

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

Package Information

Dexmethylphenidate Hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).The efficacy of dexmethylphenidate hydrochloride tablets in the treatment of ADHD was established in 2 controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and were present before age 7 years. This formulation utilizes a tablet delivery system. Marketed by Neolpharma, Inc., this product is identified by NDC 55466-122 and is authorized under FDA application ANDA209211.

Identification & Billing

NDC Package Code
55466-122-12
Package Description
100 TABLET in 1 BOTTLE
Product Code
55466-122
11-Digit Billing Format
55466012212
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dexmethylphenidate Hydrochloride
Non-Proprietary Name
Dexmethylphenidate Hydrochloride
Substance Name
Dexmethylphenidate Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).The efficacy of dexmethylphenidate hydrochloride tablets in the treatment of ADHD was established in 2 controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause 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 2 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 6 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 6 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 Type requires both inattentive and hyperactive-impulsive criteria to be met.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Neolpharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209211
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2024
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 55466-122-12 identifies a specific commercial package of 100 tablet in 1 bottle of Dexmethylphenidate Hydrochloride, a human prescription drug labeled by Neolpharma, Inc.. This tablet is formulated for oral use and contains dexmethylphenidate 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 Neolpharma, Inc. on March 29, 2024. The current certification is valid through December 31, 2026.

How is this Neolpharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55466012212. 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)
55466-122-12
11-Digit CMS (5-4-2)
55466-0122-12

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