LOKELMA
These highlights do not include all the information needed to use LOKELMA safely and effectively. See full prescribing information for LOKELMA. LOKELMA (sodium zirconium cyclosilicate) for oral suspension Initial U.S. Approval: 2018
Approved
Approval ID
8833d6e6-33ab-4ea9-b78f-3ec30a904ef8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium zirconium cyclosilicate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6501
Application NumberNDA207078
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium zirconium cyclosilicate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (1)
SODIUM ZIRCONIUM CYCLOSILICATEActive
Quantity: 10 g in 10 g
Code: D652ZWF066
Classification: ACTIB