Item Code (Source) NDC:62856-280
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK) PERAMPANEL 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 10;296
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-280-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
2 NDC:62856-280-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202834 10/22/2012
FYCOMPA
perampanel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-282
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK) PERAMPANEL 12 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
Product Characteristics
Color BLUE (blue) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 12;297
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-282-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
2 NDC:62856-282-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202834 10/22/2012
FYCOMPA
perampanel suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-290
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK) PE |
