sodium polystyrene sulfonate (35573-108)

Drug Facts

Product Profile

Brand Name sodium polystyrene sulfonate

Generic Name sodium polystyrene sulfonate

Labeler burel pharmaceuticals, llc

Dosage Form SUSPENSION

Routes

ORAL RECTAL

Active Ingredients

sodium polystyrene sulfonate 15 g/60mL

Manufacturer

Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-108

Product ID 35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214912

Listing Expiration 2026-12-31

Marketing Start 2025-12-18

Pharmacologic Class

Established (EPC)

potassium binder [epc]

Mechanism of Action

potassium ion exchange activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573108

Hyphenated Format 35573-108

Supplemental Identifiers

RxCUI

313072

UNII

1699G8679Z

NUI

N0000178378 N0000175357

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium polystyrene sulfonate (source: ndc)

Generic Name sodium polystyrene sulfonate (source: ndc)

Application Number ANDA214912 (source: ndc)

Routes

ORAL RECTAL

source: ndc

Resolved Composition

Strengths

15 g/60mL

source: ndc

Packaging

10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)

source: ndc

Packages (1)

35573-108-14 10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)

Ingredients (1)

sodium polystyrene sulfonate (15 g/60mL)

Linked Drug Pages (1)

Sodium Polystyrene Sulfonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL", "RECTAL"], "spl_id": "c4d9a8d2-f02d-4c55-b416-4a3d0c03835b", "openfda": {"nui": ["N0000178378", "N0000175357"], "unii": ["1699G8679Z"], "rxcui": ["313072"], "spl_set_id": ["8bbeae67-a7ff-4fa6-b21e-fb8617cd9197"], "pharm_class_epc": ["Potassium Binder [EPC]"], "pharm_class_moa": ["Potassium Ion Exchange Activity [MoA]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14)  / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)", "package_ndc": "35573-108-14", "marketing_start_date": "20251218"}], "brand_name": "Sodium Polystyrene Sulfonate", "product_id": "35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b", "dosage_form": "SUSPENSION", "product_ndc": "35573-108", "generic_name": "sodium polystyrene sulfonate", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Polystyrene Sulfonate", "active_ingredients": [{"name": "SODIUM POLYSTYRENE SULFONATE", "strength": "15 g/60mL"}], "application_number": "ANDA214912", "marketing_category": "ANDA", "marketing_start_date": "20251218", "listing_expiration_date": "20261231"}