NEL
PRINCIPAL DISPLAY PANEL - 12 mg Tablet
NDC 62856-282-90
90 tablets
Rx only
Fycompa™
(perampanel)
tablets
CIII
12 mg
ATTENTION PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 0.5 mg/mL Oral Suspension
NDC 62856-290-38
0.5 mg/mL
Rx only
Fycompa®
(perampanel)
ORAL SUSPENSION
CIII
0.5 mg/mL
ATTENTION PHARMACIST:
Dispense the enclosed
Medication Guide and Instructions for Use
with each prescription.
INGREDIENTS AND APPEARANCE
FYCOMPA
perampanel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-272
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK) PERAMPANEL 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color ORANGE (orange) Score no score
Shape ROUND (round) Size 7mm
Flavor Imprint Code 2;275
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-272-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
2 NDC:62856-272-90 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:62856-274
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK) PERAMPANEL 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Product Characteristics
Color RED (red) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 4;277
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-274-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012
2 NDC:62856-274-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2012& |
