DEXMETHYLPHENIDATE HYDROCHLORIDE

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, CIIInitial U.S. Approval: 2005

Approved

Approval ID

7b7e5069-6c58-4093-bb19-37d52fe67fd6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2021

Manufacturers

FDA

Ascent Pharmaceuticals, Inc.

DUNS: 080938961

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-327

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (24)

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 5 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-330

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (23)

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-329

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (22)

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 15 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YY

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-328

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (20)

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-334

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (22)

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-333

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (20)

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 35 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-332

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (20)

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-331

Application NumberANDA215523

Product Classification

Marketing Category

C73584

Generic Name

dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 10, 2021

FDA Product Classification

INGREDIENTS (22)

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WE

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Products 8

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

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