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Sodium Polystyrene Sulfonate

Sodium Polystyrene Sulfonate Powder for Suspension Cation - Exchange Resin Rx only

Approved
Approval ID

af0a64e1-4fde-4320-93a7-7801a03b7613

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 11, 2021

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

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 Code17856-0831
Application NumberANDA090313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Polystyrene Sulfonate
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateJune 10, 2021
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