Fycompa
These highlights do not include all the information needed to use FYCOMPA safely and effectively. See full prescribing information for FYCOMPA. FYCOMPA(perampanel) tablets, for oral use, CIIIFYCOMPA (perampanel) oral suspension, CIIIInitial U.S. Approval: 2012
Approved
Approval ID
ec812ea3-de3a-4271-957c-db8f692d1ae3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Catalyst Pharmaceuticals, Inc.
DUNS: 053742248
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-272
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PERAMPANELActive
Quantity: 2 mg in 1 1
Code: H821664NPK
Classification: ACTIB
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-290
Application NumberNDA208277
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
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
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-280
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (12)
PERAMPANELActive
Quantity: 10 mg in 1 1
Code: H821664NPK
Classification: ACTIB
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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 YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-274
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (10)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
PERAMPANELActive
Quantity: 4 mg in 1 1
Code: H821664NPK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-278
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (12)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)Inactive
Code: NZ94SDL6WR
Classification: IACT
PERAMPANELActive
Quantity: 8 mg in 1 1
Code: H821664NPK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
perampanel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-276
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (11)
PERAMPANELActive
Quantity: 6 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
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69616-282
Application NumberNDA202834
Product Classification
M
Marketing Category
C73594
G
Generic Name
perampanel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (11)
PERAMPANELActive
Quantity: 12 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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT