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Methylphenidate Transdermal System

These highlights do not include all the information needed to use METHYLPHENIDATE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for METHYLPHENIDATE TRANSDERMAL SYSTEM. Methylphenidate Transdermal System, CIIInitial U.S. Approval: 2006

Approved
Approval ID

7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2023

Manufacturers
FDA

PADAGIS US LLC

DUNS: 967694121

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

methylphenidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0574-2415
Application NumberNDA021514
Product Classification
M
Marketing Category
C73605
G
Generic Name
methylphenidate
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (1)

METHYLPHENIDATEActive
Quantity: 41.3 mg in 1 mg
Code: 207ZZ9QZ49
Classification: ACTIB

methylphenidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0574-2430
Application NumberNDA021514
Product Classification
M
Marketing Category
C73605
G
Generic Name
methylphenidate
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (1)

METHYLPHENIDATEActive
Quantity: 82.5 mg in 1 mg
Code: 207ZZ9QZ49
Classification: ACTIB

methylphenidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0574-2420
Application NumberNDA021514
Product Classification
M
Marketing Category
C73605
G
Generic Name
methylphenidate
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (1)

METHYLPHENIDATEActive
Quantity: 55 mg in 1 mg
Code: 207ZZ9QZ49
Classification: ACTIB

methylphenidate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0574-2410
Application NumberNDA021514
Product Classification
M
Marketing Category
C73605
G
Generic Name
methylphenidate
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (1)

METHYLPHENIDATEActive
Quantity: 27.5 mg in 1 mg
Code: 207ZZ9QZ49
Classification: ACTIB

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Methylphenidate Transdermal System - FDA Drug Approval Details