Clonazepam
CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
Approved
Approval ID
63286201-4b79-45b8-8f48-7e21dadc1408
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-529
Application NumberANDA077856
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2021
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT