Clonazepam
CLONAZEPAM TABLETS, USP
Approved
Approval ID
dd29b11f-797a-4d05-a564-8d73d1ea93e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2010
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
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 Code64725-3004
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2011
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Clonazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-3005
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2011
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT