Methylphenidate

Basic Information

Product Name

Methylphenidate

FDA Product Code

0378-8260

Regulatory Information

NDC Product Code

0378-8260

Application Number

ANDA206497

Marketing Category

C73584

Effective Date

July 1, 2021

Territorial Authority

USA

FDA Title

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 systemInitial U.S. Approval: 2006

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

METHYLPHENIDATE

Quantity: 1.1 mg in 1 h

Code: 207ZZ9QZ49

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

POLYTETRAFLUOROETHYLENE

Code: E1NC1JVS3O

Class Code: IACT

Active Moieties

Code: 207ZZ9QZ49

Methylphenidate

Basic Information

Regulatory Information

Company Information

Active Ingredients

TITANIUM DIOXIDE

MINERAL OIL

SILICON DIOXIDE

DOCUSATE SODIUM

POLYTETRAFLUOROETHYLENE

Active Moieties

METHYLPHENIDATE