Methylphenidate Hydrochloride Tablet, Extended Release
NDC Package 72162-2394-1

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 methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [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. This formulation utilizes a tablet, extended release delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-2394 and is authorized under FDA application ANDA091695.

Identification & Billing

NDC Package Code
72162-2394-1
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
72162-2394
11-Digit Billing Format
72162239401
RxNorm Crosswalk
  • RxCUI: 2001566 - methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX Rating
  • RxCUI: 2001566 - BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE HYDROCHLORIDE 36 mg/1
Pharmacologic Class
Usage Information
Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [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 Type requires both inattentive and hyperactive-impulsive criteria to be met.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA091695
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2013
Listing Expiration
12-31-2027
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 72162-2394-1 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. This tablet, extended release 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 Bryant Ranch Prepack on September 23, 2013. The current certification is valid through December 31, 2027.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162239401. 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 (5-4-1)
72162-2394-1
11-Digit CMS (5-4-2)
72162-2394-01

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