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Sodium Polystyrene Sulfonate

These highlights do not include all the information needed to use SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION safely and effectively. See full prescribing information for SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION for oral or rectal use Initial U.S. Approval: 1958

Approved
Approval ID

024b9f0b-42f0-42dd-ac2b-b46e15e45440

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 3, 2022

Manufacturers
FDA

ECI Pharmaceuticals, LLC

DUNS: 962476029

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Polystyrene Sulfonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51293-831
Application NumberANDA090313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Polystyrene Sulfonate
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateDecember 27, 2020
FDA Product Classification

INGREDIENTS (1)

SODIUM POLYSTYRENE SULFONATEActive
Quantity: 4.1 meq in 1 g
Code: 1699G8679Z
Classification: ACTIR

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Sodium Polystyrene Sulfonate - FDA Drug Approval Details