Methylphenidate Hydrochloride
These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets. Methylphenidate HCl Extended-Release Tablets CII Initial U.S. Approval: 2000
Approved
Approval ID
2bfb390f-ba99-4d21-8a9e-50fa8ec217c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-6262
Application NumberNDA021121
Product Classification
M
Marketing Category
C73605
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2011
FDA Product Classification
INGREDIENTS (16)
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 27 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Methylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6261
Application NumberNDA021121
Product Classification
M
Marketing Category
C73605
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2011
FDA Product Classification
INGREDIENTS (15)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 18 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT