Clonazepam
Clonazepam Tablets, USP 918 921 922 CIV Rx only
Approved
Approval ID
58af8964-3480-2139-e053-2991aa0a0624
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2017
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-922
Application NumberANDA077147
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2017
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
clonazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-921
Application NumberANDA077147
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2017
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CLONAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
clonazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-918
Application NumberANDA077147
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2017
FDA Product Classification
INGREDIENTS (7)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB