Diclofenac sodium
These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution, for topical use.Initial U.S. Approval:1988
Approved
Approval ID
02e90e33-384f-4e29-b508-2503def22214
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-487
Application NumberANDA212506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 20 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive
Code: VQ8ZWO78F6
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT