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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-598
Application NumberANDA204993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-599
Application NumberANDA204993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rufinamide
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2021
FDA Product Classification
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