Clobazam
These highlights do not include all the information needed to use CLOBAZAM ORAL SUSPENSION safely and effectively. See full prescribing information for CLOBAZAM ORAL SUSPENSION. CLOBAZAM oral suspension, CIV Initial U.S. Approval: 2011
Approved
Approval ID
879e57c5-47ce-4942-acbb-6263951ba591
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 13, 2023
Manufacturers
FDA
VistaPharm, LLC
DUNS: 116743084
Products 1
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 Code66689-058
Application NumberANDA210746
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobazam
Product Specifications
Route of AdministrationORAL
Effective DateMarch 13, 2023
FDA Product Classification
INGREDIENTS (16)
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLOBAZAMActive
Quantity: 2.5 mg in 1 mL
Code: 2MRO291B4U
Classification: ACTIB
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT