MedPath

Diclofenac Sodium

Diclofenac Sodium DR 75mg Tablets

Approved
Approval ID

d424ab84-2aaa-38a9-e053-2a95a90adde9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 8, 2023

Manufacturers
FDA

Advanced Rx Pharmacy of Tennessee, LLC

DUNS: 117023142

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diclofenac Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80425-0189
Application NumberANDA075185
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification

INGREDIENTS (1)

DICLOFENAC SODIUMActive
Quantity: 75 mg in 1 1
Code: QTG126297Q
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Diclofenac Sodium - FDA Drug Approval Details