NDC Code(s) : 62856-582-52, 62856-582-04, 62856-583-14, 62856-583-52, 62856-584-46
Packager : Eisai Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Banzelrufinamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-582
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUFINAMIDE(UNII: WFW942PR79)
(RUFINAMIDE - UNII:WFW942PR79) 		RUFINAMIDE200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink (pink) Score 2 pieces
Shape OVAL (OVAL) Size 15 mm
Flavor Imprint Code 262
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-582-52120 in 1 BOTTLE Type 0: Not a Combination Product14/11/2008
2NDC:62856-582-044 in 1 BOTTLE Type 0: Not a Combination Product08/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021911 11/14/2008
Banzelrufinamide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-583
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUFINAMIDE(UNII: WFW942PR79)
(RUFINAMIDE - UNII:WFW942PR79) 		RUFINAMIDE400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink (pink) Score 2 pieces
Shape OVAL (OVAL) Size 18 mm
Flavor Imprint Code 263
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-583-1414 in 1 BOTTLE Type 0: Not a Combination Product08/08/2018
2NDC:62856-583-52120 in 1 BOTTLE Type 0: Not a Combination Product14/11/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021911 11/14/2008
Banzelrufinamide SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-584
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RUFINAMIDE(UNII: WFW942PR79)
(RUFINAMIDE - UNII:WFW942PR79) 		RUFINAMIDE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLOXAMER 188(UNII: LQA7B6G8JG)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SORBITOL(UNII: 506T60A25R)
ORANGE(UNII: 5EVU04N5QU)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
Product Characteristics
Color white (White to off-white) Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-584-461 in 1 CARTON 03/03/2011
1460 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201367 03/03/2011

LABELER - Eisai Inc.(189246791)

REGISTRANT - Eisai Co., Ltd.(695153262)

Establishment
Name Address ID/FEI Business Operations
Ajinomoto Omnichem 400344442 api manufacture(62856-582, 62856-583, 62856-584)

Establishment
Name Address ID/FEI Business Operations
Bushu Pharmaceuticals, Ltd. 692386648 manufacture(62856-582, 62856-583), pack(62856-582, 62856-583)

Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions, LLC 014167995 analysis(62856-582, 62856-583)

Establishment
Name Address ID/FEI Business Operations
Delpharm Huningue 262639390 analysis(62856-584), manufacture(62856-584), pack(62856-584)

Establishment
Name Address ID/FEI Business Operations
Pharma Packaging Solutions, LLC dba Tjoapack, LLC 928861723 label(62856-582, 62856-583, 62856-584), pack(62856-582, 62856-583, 62856-584)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 62856-582-52
BANZEL ®  
(rufinamide) TABLETS
200 mg
120 tablets

NDC 62856-582-52 BANZEL® (rufinamide) TABLETS 200 mg 120 tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 62856-583 -52
BANZEL ®
(rufinamide) TABLETS
400 mg
120 tablets

NDC 62856-583-52 BANZEL® (rufinamide) TABLETS 400 mg 120 tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 62856-584-46
BANZEL ®
(rufinamide) ORAL SUSPENSION
40 mg/mL
460 mL

NDC 62856-584-46 BANZEL® (rufinamide) ORAL SUSPENSION 40 mg/mL 460 mL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 62856-584-46
BANZEL ®
(rufinamide) ORAL SUSPENSION
40 mg/mL
460 mL

PRINCIPAL DISPLAY PANEL NDC 62856-584-46 BANZEL® (rufinamide) ORAL SUSPENSION 40 mg/mL 460 mL