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
dd6a7bde-62c5-43e2-81f8-1f7dd63757b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Breckenridge Pharmaceutical, Inc.
DUNS: 150554335
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 Code51991-900
Application NumberANDA209308
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBAZAM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (7)
CLOBAZAMActive
Quantity: 10 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code51991-958
Application NumberANDA209308
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBAZAM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (7)
CLOBAZAMActive
Quantity: 5 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLOBAZAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-901
Application NumberANDA209308
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBAZAM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (7)
CLOBAZAMActive
Quantity: 20 mg in 1 1
Code: 2MRO291B4U
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT