Diclofenac Potassium
Diclofenac Potassium Tablets, USP 25 mg
Approved
Approval ID
8fdb1036-c0d8-4288-ac37-6512b05672ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
Trifluent Pharma LLC
DUNS: 117167281
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73352-086
Application NumberANDA075229
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac potassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DICLOFENAC POTASSIUMActive
Quantity: 25 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT