Clonazepam
CLONAZEPAM TABLETS, USP0.5 mg, 1 mg and 2 mg
Approved
Approval ID
ced338a8-903f-4919-bf87-a375ae8ea219
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-588
Application NumberANDA077856
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2011
FDA Product Classification
INGREDIENTS (7)
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
clonazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66336-980
Application NumberANDA077856
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2011
FDA Product Classification
INGREDIENTS (7)
CLONAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
clonazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66336-819
Application NumberANDA077856
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2011
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT