METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride 10mg Tablet
Approved
Approval ID
0fcdbdb5-4b27-4ef8-aa1c-b72d355def41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2010
Manufacturers
FDA
bryant ranch prepack
DUNS: 171714327
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 Code63629-3279
Application NumberANDA040300
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPHENIDATE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2010
FDA Product Classification
INGREDIENTS (5)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT