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, CII Initial U.S. Approval: 2005

Approved

Approval ID

2a5f78b3-8636-4d54-9d0c-cc3dda31e867

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 16, 2024

Manufacturers

FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

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 Code57664-626

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (17)

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-621

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (15)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 5 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-623

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (17)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 15 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-625

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (15)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-629

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (16)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 35 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-628

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (15)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-624

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (14)

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

Dexmethylphenidate hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code57664-622

Application NumberANDA206734

Product Classification

Marketing Category

C73584

Generic Name

Dexmethylphenidate hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 16, 2024

FDA Product Classification

INGREDIENTS (15)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

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

Code: 74G4R6TH13

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 1678OK0E08

Classification: ACTIB

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Dexmethylphenidate hydrochloride

Products 8

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Dexmethylphenidate hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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