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  5. NDC Package Code: 0378-8262-93 Methylphenidate

NDC Package 0378-8262-93 Methylphenidate

Patch Transdermal - 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:
0378-8262-93
Package Description:
30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-8262-16) / 9 h in 1 PATCH
Product Code:
0378-8262
Proprietary Name:
Methylphenidate
Non-Proprietary Name:
Methylphenidate
Substance Name:
Methylphenidate
Usage Information:
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
11-Digit NDC Billing Format:
00378826293
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 753436 - methylphenidate 10 MG/9HR Transdermal System
  • RxCUI: 753436 - 9 HR methylphenidate 1.11 MG/HR Transdermal System
  • RxCUI: 753436 - methylphenidate 1.1 MG/HR 9HR Transdermal System
  • RxCUI: 753436 - methylphenidate 10 MG per 9HR Transdermal Patch
  • RxCUI: 753438 - methylphenidate 15 MG/9HR Transdermal System
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • METHYLPHENIDATE 2.2 mg/h
    • 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:
    ANDA206497
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-27-2022
    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 0378-8262-93?

    The NDC Packaged Code 0378-8262-93 is assigned to a package of 30 pouch in 1 carton / 1 patch in 1 pouch (0378-8262-16) / 9 h in 1 patch of Methylphenidate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 0378-8262 included in the NDC Directory?

    Yes, Methylphenidate with product code 0378-8262 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on June 27, 2022 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 NDC billing unit for package 0378-8262-93?

    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 1.

    What is the 11-digit format for NDC 0378-8262-93?

    The 11-digit format is 00378826293. 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 4-4-2 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
    4-4-20378-8262-935-4-200378-8262-93