FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
17856-0024
11-digit product format
178560024
Labeler code
17856
Product ID
17856-0024_361f79e5-0981-c4de-e063-6394a90a39ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Polystyrene Sulfonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA202333
Marketing category
ANDA
Marketing start
2014-04-14
Substance
SODIUM POLYSTYRENE SULFONATE
Active strength
4.1 meq/g
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 SULFONATE4.1 meq/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1699G8679Z
Rxcui2101899

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0024-12025-03-18C16284748780-12cef2736-7a9f-d83d-e063-dadaa90ab31fSodium Polystyrene Sulfonate Powder These highlights do not include all the information needed to use Sodium Polystyrene Sulfonate Powder, for Suspension safely and effectively. See full prescribing information for Sodium Polystyrene Sulfonate Powder, for Suspension. Sodium Polystyrene Sulfonate Powder, for Suspension, for oral or rectal use Initial U.S. Approval: 1958
17856-0024-22025-03-18C16284748780-12cef2736-7a9f-d83d-e063-dadaa90ab31fSodium Polystyrene Sulfonate Powder These highlights do not include all the information needed to use Sodium Polystyrene Sulfonate Powder, for Suspension safely and effectively. See full prescribing information for Sodium Polystyrene Sulfonate Powder, for Suspension. Sodium Polystyrene Sulfonate Powder, for Suspension, for oral or rectal use Initial U.S. Approval: 1958
17856-0024-12025-01-30C16284748780-12cef2736-7a9f-d83d-e063-dadaa90ab31fSodium Polystyrene Sulfonate Powder These highlights do not include all the information needed to use Sodium Polystyrene Sulfonate Powder, for Suspension safely and effectively. See full prescribing information for Sodium Polystyrene Sulfonate Powder, for Suspension. Sodium Polystyrene Sulfonate Powder, for Suspension, for oral or rectal use Initial U.S. Approval: 1958
17856-0024-22025-01-30C16284748780-12cef2736-7a9f-d83d-e063-dadaa90ab31fSodium Polystyrene Sulfonate Powder These highlights do not include all the information needed to use Sodium Polystyrene Sulfonate Powder, for Suspension safely and effectively. See full prescribing information for Sodium Polystyrene Sulfonate Powder, for Suspension. Sodium Polystyrene Sulfonate Powder, for Suspension, for oral or rectal use Initial U.S. Approval: 1958

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0024-1Sodium Polystyrene Sulfonate50 in 1 BOX, UNIT-DOSEPOWDER, FOR SUSPENSION503
17856-0024-1Sodium Polystyrene Sulfonate15 g in 1 CUPPOWDER, FOR SUSPENSION153
17856-0024-2Sodium Polystyrene Sulfonate30 g in 1 CUPPOWDER, FOR SUSPENSION303
17856-0024-2Sodium Polystyrene Sulfonate50 in 1 BOX, UNIT-DOSEPOWDER, FOR SUSPENSION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0024SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [ATLANTIC BIOLOGICALS CORP.]3Current NDC, 4 package rows20250529_2d95d23e-94c8-4975-99f5-ce746dfbb60e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN2d95d23e-94c8-4975-99f5-ce746dfbb60e3
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD2d95d23e-94c8-4975-99f5-ce746dfbb60e3
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY2d95d23e-94c8-4975-99f5-ce746dfbb60e3
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY2d95d23e-94c8-4975-99f5-ce746dfbb60e3
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY2d95d23e-94c8-4975-99f5-ce746dfbb60e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0024-11785600240150 CUP in 1 BOX, UNIT-DOSE (17856-0024-1) / 15 g in 1 CUP50 cup2023-04-11NoNoCurrent
17856-0024-21785600240250 CUP in 1 BOX, UNIT-DOSE (17856-0024-2) / 30 g in 1 CUP50 cup2023-04-11NoNoCurrent