sodium polystyrene sulfonate (17856-0831)

Drug Facts

Product Profile

Brand Name sodium polystyrene sulfonate

Generic Name sodium polystyrene sulfonate

Labeler atlantic biologicals corp.

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL RECTAL

Active Ingredients

sodium polystyrene sulfonate 4.1 meq/g

Manufacturer

ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0831

Product ID 17856-0831_3b2c7913-ae12-cea1-e063-6394a90a6e0e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090313

Listing Expiration 2026-12-31

Marketing Start 2017-02-07

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 178560831

Hyphenated Format 17856-0831

Supplemental Identifiers

RxCUI

2101899

UNII

1699G8679Z

NUI

N0000178378 N0000175357

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 ANDA090313 (source: ndc)

Routes

ORAL RECTAL

source: ndc

Resolved Composition

Strengths

4.1 meq/g

source: ndc

Packaging

HOW SUPPLIED Sodium polystyrene sulfonate is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g), NDC 51293-831-97 Store at 25° C (77º F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature] DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. 20101 N.E 16TH PLACE MIAMI, FL 33179
PRINCIPAL DISPLAY PANEL - 4.1mEq jar NDC 17856-0831-1 Rx Only Sodium Polystyrene Sulfonate, USP Average adult dose: 15 g (approximately 4 level Teaspoons) one to four times daily in water. See complete prescribing information. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Sodium content approximately 60 mEq per 15 g. Suspension should be freshly prepared and not stored beyond 24 hours. Dispense in tight, light-resistant containers as defined in the official compendia. Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature] 15G (1 lb) DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179 image description image description

source: label

Packages (0)

No package records.

Ingredients (1)

sodium polystyrene sulfonate (4.1 meq/g)

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": "3b2c7913-ae12-cea1-e063-6394a90a6e0e", "openfda": {"nui": ["N0000178378", "N0000175357"], "unii": ["1699G8679Z"], "rxcui": ["2101899"], "spl_set_id": ["af0a64e1-4fde-4320-93a7-7801a03b7613"], "pharm_class_epc": ["Potassium Binder [EPC]"], "pharm_class_moa": ["Potassium Ion Exchange Activity [MoA]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [], "brand_name": "Sodium Polystyrene Sulfonate", "product_id": "17856-0831_3b2c7913-ae12-cea1-e063-6394a90a6e0e", "dosage_form": "POWDER, FOR SUSPENSION", "product_ndc": "17856-0831", "generic_name": "Sodium Polystyrene Sulfonate", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Polystyrene Sulfonate", "active_ingredients": [{"name": "SODIUM POLYSTYRENE SULFONATE", "strength": "4.1 meq/g"}], "application_number": "ANDA090313", "marketing_category": "ANDA", "marketing_start_date": "20170207", "listing_expiration_date": "20261231"}