Diclofenac Potassium
Diclofenac Potassium Tablets, USP 50mg
Approved
Approval ID
f2908870-a517-491f-8771-4100d11b4b64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2023
Manufacturers
FDA
Amici Pharmaceuticals LLC.
DUNS: 079536824
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 Code69292-550
Application NumberANDA076561
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac potassium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2020
FDA Product Classification
INGREDIENTS (11)
DICLOFENAC POTASSIUMActive
Quantity: 50 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT