sodium polystyrene sulfonate

Generic: sodium polystyrene sulfonate

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium polystyrene sulfonate
Generic Name sodium polystyrene sulfonate
Labeler sunrise pharmaceutical, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL RECTAL
Active Ingredients

sodium polystyrene sulfonate 4.1 meq/g

Manufacturer
SUNRISE PHARMACEUTICAL, INC.

Identifiers & Regulatory

Product NDC 11534-166
Product ID 11534-166_c5432731-23bc-44cf-bfcc-e59d16437db2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204071
Listing Expiration 2026-12-31
Marketing Start 2017-01-24

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 11534166
Hyphenated Format 11534-166

Supplemental Identifiers

RxCUI
2101899
UPC
0311534166446
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 ANDA204071 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 4.1 meq/g
source: ndc
Packaging
  • 15 g in 1 BOTTLE (11534-166-15)
  • 15 g in 1 BOTTLE (11534-166-16)
  • 454 g in 1 JAR (11534-166-44)
source: ndc

Packages (3)

11534-166-15 15 g in 1 BOTTLE (11534-166-15) 11534-166-16 15 g in 1 BOTTLE (11534-166-16) 11534-166-44 454 g in 1 JAR (11534-166-44)

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": "c5432731-23bc-44cf-bfcc-e59d16437db2", "openfda": {"nui": ["N0000178378", "N0000175357"], "upc": ["0311534166446"], "unii": ["1699G8679Z"], "rxcui": ["2101899"], "spl_set_id": ["c73b9661-2378-4336-8be0-098e7c1ae522"], "pharm_class_epc": ["Potassium Binder [EPC]"], "pharm_class_moa": ["Potassium Ion Exchange Activity [MoA]"], "manufacturer_name": ["SUNRISE PHARMACEUTICAL, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOTTLE (11534-166-15)", "package_ndc": "11534-166-15", "marketing_start_date": "20170124"}, {"sample": false, "description": "15 g in 1 BOTTLE (11534-166-16)", "package_ndc": "11534-166-16", "marketing_start_date": "20170124"}, {"sample": false, "description": "454 g in 1 JAR (11534-166-44)", "package_ndc": "11534-166-44", "marketing_start_date": "20170124"}], "brand_name": "SODIUM POLYSTYRENE SULFONATE", "product_id": "11534-166_c5432731-23bc-44cf-bfcc-e59d16437db2", "dosage_form": "POWDER, FOR SUSPENSION", "product_ndc": "11534-166", "generic_name": "sodium polystyrene sulfonate", "labeler_name": "SUNRISE PHARMACEUTICAL, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SODIUM POLYSTYRENE SULFONATE", "active_ingredients": [{"name": "SODIUM POLYSTYRENE SULFONATE", "strength": "4.1 meq/g"}], "application_number": "ANDA204071", "marketing_category": "ANDA", "marketing_start_date": "20170124", "listing_expiration_date": "20261231"}