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

dad446b7-b26c-44f2-9e30-4cbd10d8b23c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 29, 2023

Manufacturers

FDA

Patriot Pharmaceuticals, LLC.

DUNS: 178220385

Products 4

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 Code10147-0687

Application NumberNDA021121

Product Classification

Marketing Category

C73605

Generic Name

methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (16)

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 54 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10147-0688

Application NumberNDA021121

Product Classification

Marketing Category

C73605

Generic Name

methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (16)

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 27 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10147-0685

Application NumberNDA021121

Product Classification

Marketing Category

C73594

Generic Name

methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (16)

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 18 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code10147-0686

Application NumberNDA021121

Product Classification

Marketing Category

C73605

Generic Name

methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (16)

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 36 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

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methylphenidate Hydrochloride

Products 4

methylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

methylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

methylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

methylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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