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 1.5% w/w is for topical use only. Initial U.S. Approval: 1988
Approved
Approval ID
9aefa19d-8644-2314-e053-2a95a90a130a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
medsource pharmaceuticals
DUNS: 833685915
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 Code45865-964
Application NumberANDA202769
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2019
FDA Product Classification
INGREDIENTS (6)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT