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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

7f7ed64d-8480-4143-a207-29c24a0b9363

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 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 Code50090-6502
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: 5 g in 5 g
Code: D652ZWF066
Classification: ACTIB

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LOKELMA - FDA Drug Approval Details