rufinamide
These highlights do not include all the information needed to use RUFINAMIDE TABLETS safely and effectively. See full prescribing information for RUFINAMIDE TABLETS. RUFINAMIDE tablets, for oral useInitial U.S. Approval: 2008
Approved
Approval ID
da9ee326-a383-4d46-9d4e-fcc2be3d2680
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2021
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 2
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 Code68462-714
Application NumberANDA205075
Product Classification
M
Marketing Category
C73584
G
Generic Name
rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2021
FDA Product Classification
INGREDIENTS (13)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
RUFINAMIDEActive
Quantity: 400 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
rufinamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-713
Application NumberANDA205075
Product Classification
M
Marketing Category
C73584
G
Generic Name
rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2021
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
RUFINAMIDEActive
Quantity: 200 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT