Diclofenac sodium
Diclofenac Sodium Gel, 3%
Approved
Approval ID
95cf9923-a45b-4735-843e-555239900fe3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2022
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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 Code55700-980
Application NumberANDA206298
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2022
FDA Product Classification
INGREDIENTS (4)
diclofenac sodiumActive
Quantity: 30 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
hyaluronate sodiumInactive
Code: YSE9PPT4TH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT