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  5. NDC Package Code: 72162-2394-1 Methylphenidate Hydrochloride

NDC Package 72162-2394-1 Methylphenidate Hydrochloride

Tablet, Extended Release 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:
72162-2394-1
Package Description:
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
72162-2394
Proprietary Name:
Methylphenidate Hydrochloride
Non-Proprietary Name:
Methylphenidate Hydrochloride
Substance Name:
Methylphenidate Hydrochloride
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.
11-Digit NDC Billing Format:
72162239401
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Bryant Ranch Prepack
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
METHYLPHENIDATE HYDROCHLORIDE 36 mg/1
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA091695
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-23-2013
Listing Expiration Date:
12-31-2025
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 72162-2394-1?

The NDC Packaged Code 72162-2394-1 is assigned to a package of 100 tablet, extended release in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 72162-2394 included in the NDC Directory?

Yes, Methylphenidate Hydrochloride with product code 72162-2394 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on September 23, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 72162-2394-1?

The 11-digit format is 72162239401. 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
5-4-172162-2394-15-4-272162-2394-01