Diclofenac Sodium
Diclofenac Sodium
Approved
Approval ID
f80b0b95-f4da-2d6c-e053-6294a90acf92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2023
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-454
Application NumberANDA203818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 29, 2023
FDA Product Classification
INGREDIENTS (6)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT