MedPath

Clonazepam

CLONAZEPAM TABLETS, USP 1 mg CIV Rx only

Approved
Approval ID

ca79f244-7e6e-4612-af26-e6e5cefbd3a2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 14, 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

NDC Product Code72789-314
Application NumberANDA077856
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2023
Generic Nameclonazepam

INGREDIENTS (7)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLONAZEPAMActive
Quantity: 1 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB

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Clonazepam - FDA Drug Approval Details