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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

a9ed75ff-0adc-498e-b230-1d14f3eade64

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-2031
Application NumberANDA090313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Polystyrene Sulfonate
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateMarch 8, 2022
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