MedPath

Diclofenac Sodium

Approved
Approval ID

44b76125-05bd-42fe-a3e8-1d8ec39984e5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2019

Manufacturers
FDA

Two Hip Consulting, LLC

DUNS: 965352896

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 Code76074-501
Product Classification
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 11, 2016
FDA Product Classification

INGREDIENTS (5)

DICLOFENAC SODIUMActive
Quantity: 3 g in 100 g
Code: QTG126297Q
Classification: ACTIB
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
METHOXY PEG-40Inactive
Code: 6AXS45P1QU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Diclofenac Sodium - FDA Drug Approval Details