Diclofenac Potassium
Diclofenac Potassium Tablets, USP Rx only Prescribing Information
Approved
Approval ID
1fa07fbe-3708-4200-b3ff-a920434896b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
UMEDICA LABORATORIES PRIVATE LIMITED
DUNS: 920635096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Potassium Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-057
Application NumberANDA215750
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Potassium Tablets
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DICLOFENAC POTASSIUMActive
Quantity: 50 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB