Fycompa

These highlights do not include all the information needed to use FYCOMPA safely and effectively. See full prescribing information for FYCOMPA . FYCOMPA (perampanel) t ablets , for oral use , CIII FYCOMPA (perampanel) o ral s uspension , CIII Initial U.S. Approval: 20 12

Approved

Approval ID

71cf3309-e182-473c-8b0b-280cabd0e122

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers

FDA

Eisai Inc.

DUNS: 189246791

Products 7

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

perampanel

PRODUCT DETAILS

NDC Product Code62856-282

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (11)

PERAMPANELActive

Quantity: 12 mg in 1 1

Code: H821664NPK

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-274

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (10)

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

PERAMPANELActive

Quantity: 4 mg in 1 1

Code: H821664NPK

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-290

Application NumberNDA208277

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (10)

PERAMPANELActive

Quantity: 0.5 mg in 1 mL

Code: H821664NPK

Classification: ACTIB

SORBITOLInactive

Code: 506T60A25R

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUMInactive

Code: K679OBS311

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-276

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

PERAMPANELActive

Quantity: 6 mg in 1 1

Code: H821664NPK

Classification: ACTIB

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-272

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (11)

PERAMPANELActive

Quantity: 2 mg in 1 1

Code: H821664NPK

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-278

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (12)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

PERAMPANELActive

Quantity: 8 mg in 1 1

Code: H821664NPK

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

perampanel

PRODUCT DETAILS

NDC Product Code62856-280

Application NumberNDA202834

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateNovember 21, 2023

Generic Nameperampanel

INGREDIENTS (12)

PERAMPANELActive

Quantity: 10 mg in 1 1

Code: H821664NPK

Classification: ACTIB

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive

Code: NZ94SDL6WR

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

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Fycompa

Products 7

perampanel

PRODUCT DETAILS

INGREDIENTS (11)

perampanel

PRODUCT DETAILS

INGREDIENTS (10)

perampanel

PRODUCT DETAILS

INGREDIENTS (10)

perampanel

PRODUCT DETAILS

INGREDIENTS (11)

perampanel

PRODUCT DETAILS

INGREDIENTS (11)

perampanel

PRODUCT DETAILS

INGREDIENTS (12)

perampanel

PRODUCT DETAILS

INGREDIENTS (12)

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