Clonazepam
Clonazepam Tablets, USP Rx only
Approved
Approval ID
1ce88d2c-70f7-427b-8787-4afd9ce6f71c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-788
Application NumberANDA077147
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CLONAZEPAMActive
Quantity: 2 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT