Clonazepam
CLONAZEPAM TABLETS, USP CIV
Approved
Approval ID
34fd5bee-5fbe-418b-831b-0a338656a43e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2020
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-7451
Application NumberANDA074869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2020
FDA Product Classification
INGREDIENTS (6)
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT