MedPath
FDA Product

Rufinamide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Rufinamide

59651-616

Regulatory Information

59651-616

ANDA217230

C73584

December 6, 2022

USA

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 use Initial U.S. Approval: 2008

Human Prescription Drug Label

1

Company Information

650082092

Active Ingredients

RUFINAMIDE

Quantity: 200 mg in 1 1

Code: WFW942PR79

Class Code: ACTIB

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL 4000

Code: 4R4HFI6D95

Class Code: IACT

Active Moieties

RUFINAMIDE

Code: WFW942PR79

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