Concerta

These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA (methylphenidate HCl) Extended-Release Tablets CIIInitial U.S. Approval: 2000

Approved

Approval ID

f63155b9-ea71-4a30-be32-37173f87bcbf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2010

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-4489

Application NumberNDA021121

Product Classification

Marketing Category

C73594

Generic Name

Methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 29, 2010

FDA Product Classification

INGREDIENTS (16)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 18 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIM

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4957

Application NumberNDA021121

Product Classification

Marketing Category

C73594

Generic Name

Methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 29, 2010

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 27 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIM

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4759

Application NumberNDA021121

Product Classification

Marketing Category

C73594

Generic Name

Methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 29, 2010

FDA Product Classification

INGREDIENTS (16)

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 36 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIM

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Methylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-4789

Application NumberNDA021121

Product Classification

Marketing Category

C73594

Generic Name

Methylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 29, 2010

FDA Product Classification

INGREDIENTS (16)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 54 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIM

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171K

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

PHOSPHORIC ACIDInactive

Code: E4GA8884NN

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSEInactive

Code: J2B2A4N98G

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SUCCINIC ACIDInactive

Code: AB6MNQ6J6L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

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Concerta

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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