FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
55154-7353
11-digit product format
551547353
Labeler code
55154
Product ID
55154-7353_f1158403-506e-4083-82b8-a0ef7dc757d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium polystyrene sulfonate
Dosage form
SUSPENSION
Route
ORAL; RECTAL
Labeler
Cardinal Health 107, LLC
Application
ANDA087859
Marketing category
ANDA
Marketing start
1983-01-01
Substance
SODIUM POLYSTYRENE SULFONATE
Active strength
15 g/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Polystyrene Sulfonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM POLYSTYRENE SULFONATE15 g/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1699G8679Z
Rxcui313072

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7353-2Sodium Polystyrene Sulfonate2 in 1 BAGSUSPENSION210
55154-7353-2Sodium Polystyrene Sulfonate60 mL in 1 BOTTLE, UNIT-DOSESUSPENSION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-7353-2ML - Milliliter55154-735387dfee85-8e29-4ea6-af46-2efb5f18968512019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM POLYSTYRENE SULFONATEACTIVE INGREDIENT1699G8679ZSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
POLYSTYRENE SULFONIC ACIDACTIVE MOIETY70KO0R01RYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7353SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20240214_3c3b02a3-9a75-40a5-889d-97318faf881f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313072sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal SuspensionPSN3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 250 MG/ML Oral SuspensionSCD3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 15 GM per 60 ML Oral SuspensionSY3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 30 GM per 120 ML Oral SuspensionSY3c3b02a3-9a75-40a5-889d-97318faf881f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-7353-2551547353022 BOTTLE, UNIT-DOSE in 1 BAG (55154-7353-2) / 60 mL in 1 BOTTLE, UNIT-DOSE1983-01-010000-00-00NoNoCurrent