MedPath

Clonazepam

CLONAZEPAM TABLETS USP CIV Rx only

Approved
Approval ID

429a15d1-1675-42cc-97f1-c49b03747416

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Clinical Solutions Wholesale, LLC

DUNS: 078710347

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 Code58118-0832
Application NumberANDA074569
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clonazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (7)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CLONAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: 5PE9FDE8GB
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Clonazepam - FDA Drug Approval Details