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 film-coated tablet, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
afe24968-e078-46d6-a776-b2608734e03e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2021
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rufinamide
PRODUCT DETAILS
NDC Product Code31722-598
Application NumberANDA204993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 2, 2021
Generic NameRufinamide
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RUFINAMIDEActive
Quantity: 200 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
Rufinamide
PRODUCT DETAILS
NDC Product Code31722-599
Application NumberANDA204993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 2, 2021
Generic NameRufinamide
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
RUFINAMIDEActive
Quantity: 400 mg in 1 1
Code: WFW942PR79
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT