Methylphenidate Hydrochloride (LA)

These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955

Approved

Approval ID

e5db854a-1c77-4faf-9e60-daf9c9b6cfa0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 23, 2023

Manufacturers

FDA

Mayne Pharma

DUNS: 867220261

Products 5

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 Code51862-614

Application NumberANDA078458

Product Classification

Marketing Category

C73584

Generic Name

Methylphenidate Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2022

FDA Product Classification

INGREDIENTS (18)

Methylphenidate HydrochlorideActive

Quantity: 60 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZ

Classification: IACT

HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive

Code: 36BGF0E889

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Methylphenidate Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51862-611

Application NumberANDA078458

Product Classification

Marketing Category

C73584

Generic Name

Methylphenidate Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2022

FDA Product Classification

INGREDIENTS (18)

Methylphenidate HydrochlorideActive

Quantity: 30 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive

Code: 36BGF0E889

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Methylphenidate Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51862-612

Application NumberANDA078458

Product Classification

Marketing Category

C73584

Generic Name

Methylphenidate Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2022

FDA Product Classification

INGREDIENTS (18)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Methylphenidate HydrochlorideActive

Quantity: 40 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive

Code: 36BGF0E889

Classification: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZ

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Methylphenidate Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51862-610

Application NumberANDA078458

Product Classification

Marketing Category

C73584

Generic Name

Methylphenidate Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2022

FDA Product Classification

INGREDIENTS (18)

HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive

Code: 36BGF0E889

Classification: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZ

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Methylphenidate HydrochlorideActive

Quantity: 20 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

Methylphenidate Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51862-609

Application NumberANDA200886

Product Classification

Marketing Category

C73584

Generic Name

Methylphenidate Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateNovember 1, 2022

FDA Product Classification

INGREDIENTS (20)

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

Methylphenidate HydrochlorideActive

Quantity: 10 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6

Classification: IACT

HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive

Code: 36BGF0E889

Classification: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZ

Classification: IACT

ACETONEInactive

Code: 1364PS73AF

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Methylphenidate Hydrochloride (LA)

Products 5

Methylphenidate Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Methylphenidate Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Methylphenidate Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Methylphenidate Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Methylphenidate Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

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