Fycompa (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet

NDC 62856-280-90

90 tablets

Rx only

Fycompa™
(perampanel)
tablets

CIII

10 mg

ATTENTION PHARMACIST:
Dispense the accompanyingMedication Guide to each patient.

NDC 62856-280-90
90 tablets
Rx only
Fycompa™
(perampanel)
tablets
CIII
10 mg
ATTENTION PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12 mg Tablet

NDC 62856-282-30

30 tablets

Rx only

Fycompa™
(perampanel)
tablets

CIII

12 mg

ATTENTION PHARMACIST:
Dispense the accompanyingMedication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 12 mg Tablet
NDC 62856-282-30
30 tablets
Rx only
Fycompa™
(perampanel)
tablets
CIII
12 mg
ATTENTION PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.
(click image for full-size original)
PRINCIPAL DISPLAY PANEL -- 12 mg Tablet
NDC 62856-282-30
30 tablets
Rx only
Fycompa™
(perampanel)
tablets
CIII
12 mg
ATTENTION PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12 mg Tablet

NDC 62856-282-90

90 tablets

Rx only

Fycompa™
(perampanel)
tablets

CIII

12 mg

ATTENTION PHARMACIST:
Dispense the accompanyingMedication Guide to each patient.

NDC 62856-282-90
90 tablets
Rx only
Fycompa™
(perampanel)
tablets
CIII
12 mg
ATTENTION PHARMACIST:
Dispense the accompanying
Medication Guide to each patient.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mg/mL Oral Suspension

NDC 62856-290-38

0.5 mg/mL

Rx only

Fycompa®
(perampanel)ORAL SUSPENSION

CIII

340 mL

NDC 62856-290-38
0.5 mg/mL
Rx only
Fycompa®
(perampanel)
ORAL SUSPENSION
CIII
340 mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mg/mL Oral Suspension

NDC 62856-290-38

0.5 mg/mL

Rx only

Fycompa®
(perampanel)ORAL SUSPENSION

CIII

340 mL

NDC 62856-290-38
0.5 mg/mL
Rx only
Fycompa®
(perampanel)
ORAL SUSPENSION
CIII
340 mL
(click image for full-size original)

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 (PERAMPANEL) PERAMPANEL 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange (orange) Score no score
Shape ROUND (round) Size 7mm
Flavor Imprint Code 2;275
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-272-30 30 TABLET in 1 BOTTLE None
2 NDC:62856-272-90 90 TABLET in 1 BOTTLE None
3 NDC:62856-272-14 14 TABLET in 1 PACKET None
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 (PERAMPANEL) PERAMPANEL 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color red (red) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 4;277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-274-14 14 TABLET in 1 PACKET None
2 NDC:62856-274-30 30 TABLET in 1 BOTTLE None
3 NDC:62856-274-90 90 TABLET in 1 BOTTLE None
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:62856-276
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (PERAMPANEL) PERAMPANEL 6 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color pink (pink) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 6;294
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-276-30 30 TABLET in 1 BOTTLE None
2 NDC:62856-276-90 90 TABLET in 1 BOTTLE None
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:62856-278
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (PERAMPANEL) PERAMPANEL 8 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color purple (purple) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 8;295
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-278-30 30 TABLET in 1 BOTTLE None
2 NDC:62856-278-90 90 TABLET in 1 BOTTLE None
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:62856-280
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERAMPANEL (PERAMPANEL) PERAMPANEL 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color green (green) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 10;296
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-280-30 30 TABLET in 1 BOTTLE None
2 NDC:62856-280-90 90 TABLET in 1 BOTTLE None
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 (PERAMPANEL) PERAMPANEL 12 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color blue (blue) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code 12;297
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-282-30 30 TABLET in 1 BOTTLE None
2 NDC:62856-282-90 90 TABLET in 1 BOTTLE None
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 (PERAMPANEL) PERAMPANEL 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
POLOXAMER 188
SILICON DIOXIDE
DIMETHICONE
ANHYDROUS CITRIC ACID
SODIUM BENZOATE
WATER
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-290-38 340 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208277 04/30/2016
Labeler — Eisai Inc. (189246791)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 014167995 analysis (62856-272), analysis (62856-274), analysis (62856-276), analysis (62856-278), analysis (62856-280), analysis (62856-282)
Establishment
Name Address ID/FEI Operations
Delpharm Huningue 262639390 analysis (62856-290), manufacture (62856-290), pack (62856-290)
Establishment
Name Address ID/FEI Operations
Eisai Co., Ltd. 695153247 manufacture (62856-272), manufacture (62856-274), manufacture (62856-276), manufacture (62856-278), manufacture (62856-280), manufacture (62856-282)
Establishment
Name Address ID/FEI Operations
Eisai Co., Ltd. 695319983 api manufacture (62856-272), api manufacture (62856-274), api manufacture (62856-276), api manufacture (62856-278), api manufacture (62856-280), api manufacture (62856-282), api manufacture (62856-290)
Establishment
Name Address ID/FEI Operations
Eisai Manufacturing Ltd 219516916 manufacture (62856-272), manufacture (62856-274), manufacture (62856-276), manufacture (62856-278), manufacture (62856-280), manufacture (62856-282)
Establishment
Name Address ID/FEI Operations
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. 431189117 api manufacture (62856-272), api manufacture (62856-274), api manufacture (62856-276), api manufacture (62856-278), api manufacture (62856-280), api manufacture (62856-282)
Establishment
Name Address ID/FEI Operations
Pharma Packaging Solutions, LLC dba Tjoapack, LLC 928861723 label (62856-272), label (62856-274), label (62856-276), label (62856-278), label (62856-280), label (62856-282), label (62856-290), pack (62856-272), pack (62856-274), pack (62856-276), pack (62856-278), pack (62856-280), pack (62856-282), pack (62856-290)

Revised: 11/2023 Eisai Inc.

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