DEXMETHYLPHENIDATE HYDROCHLORIDE

Dexmethylphenidate hydrochloride extended-release capsules These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005

Approved

Approval ID

abe6862b-3cf3-4aad-98ea-05a5fb54ebec

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 10, 2023

Manufacturers

FDA

Granules Pharmaceuticals Inc.

DUNS: 079825711

Products 8

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-006

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (16)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 15 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-004

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (16)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 5 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-007

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (14)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-005

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (15)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-008

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (16)

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-011

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (16)

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-010

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (17)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 35 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

NDC Product Code70010-009

Application NumberANDA213813

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 10, 2023

Generic NameDEXMETHYLPHENIDATE HYDROCHLORIDE

INGREDIENTS (15)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: MB5IUD6JUA

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Products 8

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (16)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (16)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (14)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (15)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (16)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (16)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (17)

DEXMETHYLPHENIDATE HYDROCHLORIDE

PRODUCT DETAILS

INGREDIENTS (15)