Clobazam
These highlights do not include all the information needed to use CLOBAZAM TABLETS safely and effectively. See full prescribing information for CLOBAZAM TABLETS. CLOBAZAM tablets, for oral use, CIV Initial U.S. Approval: 2011
Approved
Approval ID
df304c15-5c5a-43e5-8f3c-9520b0d50e46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
Sandoz Inc.
DUNS: 005387188
Products 2
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 Code0781-8014
Application NumberANDA209808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobazam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLOBAZAMActive
Quantity: 20 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Clobazam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-8013
Application NumberANDA209808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobazam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLOBAZAMActive
Quantity: 10 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT