Onfi
These highlights do not include all the information needed to use ONFI safely and effectively. See full prescribing information for ONFI. ONFI (clobazam) tablets, for oral use, CIV ONFI (clobazam) oral suspension, CIV Initial U.S. Approval: 2011
Approved
Approval ID
de03bd69-2dca-459c-93b4-541fd3e9571c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 12, 2024
Manufacturers
FDA
Lundbeck Pharmaceuticals LLC
DUNS: 009582068
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clobazam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67386-313
Application NumberNDA203993
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobazam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2024
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CLOBAZAMActive
Quantity: 2.5 mg in 1 mL
Code: 2MRO291B4U
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
clobazam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67386-314
Application NumberNDA202067
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobazam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2024
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLOBAZAMActive
Quantity: 10 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
clobazam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67386-315
Application NumberNDA202067
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobazam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2024
FDA Product Classification
INGREDIENTS (6)
CLOBAZAMActive
Quantity: 20 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT