Methylphenidate Hydrochloride
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use CIIInitial U.S. Approval: 2000
Approved
Approval ID
a7f8225b-ad17-43b2-abc4-e0d340a22562
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
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 Code63629-2461
Application NumberANDA205327
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (15)
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 36 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
POLYETHYLENE OXIDE 5000000Inactive
Code: 3IG9032SAH
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT