Banzel
These highlights do not include all the information needed to use BANZEL safely and effectively. See full prescribing information for BANZEL . BANZEL (rufinamide) film - coated t ablet, for o ral u se BANZEL (rufinamide) o ral s uspension Initial U.S. Approval: 2008
Approved
Approval ID
0a3fa925-1abd-458a-bd57-4ae780a1ef2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2022
Manufacturers
FDA
Eisai Inc.
DUNS: 189246791
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rufinamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-584
Application NumberNDA201367
Product Classification
M
Marketing Category
C73594
G
Generic Name
rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (14)
RUFINAMIDEActive
Quantity: 40 mg in 1 mL
Code: WFW942PR79
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
rufinamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-583
Application NumberNDA021911
Product Classification
M
Marketing Category
C73594
G
Generic Name
rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (14)
RUFINAMIDEActive
Quantity: 400 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
rufinamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-582
Application NumberNDA021911
Product Classification
M
Marketing Category
C73594
G
Generic Name
rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (14)
RUFINAMIDEActive
Quantity: 200 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT