Sodium Polystyrene Sulfonate
NDC 10135-146
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Sodium Polystyrene Sulfonate is a ANDA-approved product labeled by Marlex Pharmaceuticals Inc. This medication is used to treat a high level of potassium in your blood. It is supplied as a brown product. This product entry covers the primary NDC 10135-146 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
10135-146
Proprietary Name:
Sodium Polystyrene Sulfonate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
10135
Product Label ID:
FDA Application Number: [6]
ANDA204071
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-01-2016
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I
Product Characteristics
Color(s):
BROWN (C48332 - GOLDEN BROWN)
Code Structure Chart
Product Details
What is NDC 10135-146?
The NDC code 10135-146 is assigned by the FDA to the product Sodium Polystyrene Sulfonate. This pharmaceutical product is labeled by Marlex Pharmaceuticals Inc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 10135-146-14, 10135-146-17. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to treat a high level of potassium in your blood. Too much potassium in your blood can sometimes cause heart rhythm problems. Sodium polystyrene sulfonate works by helping your body get rid of extra potassium.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
- POLYSTYRENE SULFONIC ACID (UNII: 70KO0R01RY) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2101899 - sodium polystyrene sulfonate 15 GM Powder for Suspension
- RxCUI: 2101899 - sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension
- RxCUI: 2101899 - sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension
- RxCUI: 2101899 - sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension
- RxCUI: 2101899 - sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
