CLONAZEPAM
CLONAZEPAM TABLETS, USP
Approved
Approval ID
ae7bbf44-c5af-4bda-bc22-2388498ad529
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2011
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CLONAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-059
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLONAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2011
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CLONAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-058
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLONAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2011
FDA Product Classification
INGREDIENTS (6)
CLONAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CLONAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-481
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLONAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2011
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT