Rufinamide
These highlights do not include all the information needed to use RUFINAMIDE ORAL SUSPENSION safely and effectively. See full prescribing information for RUFINAMIDE ORAL SUSPENSION. RUFINAMIDE oral suspension Initial U.S. Approval: 2008
Approved
Approval ID
1c2f9bf2-1711-4975-af02-32614db25add
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rufinamide
PRODUCT DETAILS
NDC Product Code31722-688
Application NumberANDA216841
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameRufinamide
INGREDIENTS (14)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
RUFINAMIDEActive
Quantity: 40 mg in 1 mL
Code: WFW942PR79
Classification: ACTIB
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT