METHYLPHENIDATE
Approved
Approval ID
d356f9f6-d094-478d-bf79-7781490588cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2009
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHYLPHENIDATE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-837
Application NumberANDA040220
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPHENIDATE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2009
FDA Product Classification
INGREDIENTS (1)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB