Sodium Polystyrene Sulfonate

Product NDC
35573-108
11-digit product format
355730108
Labeler code
35573
Product ID
35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium polystyrene sulfonate
Dosage form
SUSPENSION
Route
ORAL; RECTAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA214912
Marketing category
ANDA
Marketing start
2025-12-18
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
35573-108-13Sodium Polystyrene Sulfonate60 mL in 1 BOTTLE, UNIT-DOSESUSPENSION601
35573-108-14Sodium Polystyrene Sulfonate10 in 1 CARTONSUSPENSION101
35573-108-57Sodium Polystyrene Sulfonate473 mL in 1 BOTTLESUSPENSION4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313072sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal SuspensionPSN8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 250 MG/ML Oral SuspensionSCD8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 15 GM per 60 ML Oral SuspensionSY8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 30 GM per 120 ML Oral SuspensionSY8bbeae67-a7ff-4fa6-b21e-fb8617cd91971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-108-133557301081360 mL in 1 BOTTLE, UNIT-DOSE60 mlHistorical
35573-108-143557301081410 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13) 2025-12-18NoNoCurrent
35573-108-5735573010857473 mL in 1 BOTTLE473 mlHistorical