Diclofenac Potassium
DICLOFENAC POTASSIUM TABLETS USP, 50 mg Rx only
Approved
Approval ID
0d83cab3-c698-4763-9e77-27d72ba94e30
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Archis Pharma LLC
DUNS: 026836212
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 Code72819-151
Application NumberANDA075463
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac potassium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DICLOFENAC POTASSIUMActive
Quantity: 50 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB