DICLOFENAC POTASSIUM
These highlights do not include all the information needed to use Diclofenac Potassium safely and effectively. See full prescribing information for Diclofenac Potassium. Diclofenac Potassium powder, for oral solution Initial U.S. Approval: 1988
Approved
Approval ID
9dd418b2-4b0e-498c-b453-f580c69ddc6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Leading Pharma, LLC
DUNS: 079575060
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 Code69315-506
Application NumberNDA022165
Product Classification
M
Marketing Category
C73605
G
Generic Name
DICLOFENAC POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
DICLOFENAC POTASSIUMActive
Quantity: 50 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT