FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
42806-013
11-digit product format
428060013
Labeler code
42806
Product ID
42806-013_b177069d-1a6b-490c-b17a-a2399d99685f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Polystyrene Sulfonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Epic Pharma, LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-013-94Sodium Polystyrene Sulfonate15 g in 1 BOTTLEPOWDER, FOR SUSPENSION1513
42806-013-96Sodium Polystyrene Sulfonate453.6 g in 1 JARPOWDER, FOR SUSPENSION453.613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-013-94GM - Gram42806-013c6379345-1e0e-40a6-977e-0a4485ed7c7f12023-05-05
42806-013-96GM - Gram42806-013b6203e68-aea6-411b-8b1c-ff44fd78742212014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM POLYSTYRENE SULFONATEACTIVE INGREDIENT1699G8679ZSODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]6
POLYSTYRENE SULFONIC ACIDACTIVE MOIETY70KO0R01RYSODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-013SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]13Current NDC, Legacy NDC, 2 package rows20231221_61cc890b-eb3d-494c-ae45-629a27e721ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN61cc890b-eb3d-494c-ae45-629a27e721ce13
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD61cc890b-eb3d-494c-ae45-629a27e721ce13
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY61cc890b-eb3d-494c-ae45-629a27e721ce13
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY61cc890b-eb3d-494c-ae45-629a27e721ce13
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY61cc890b-eb3d-494c-ae45-629a27e721ce13
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 startMarketing endSampleExclude flagStatus
42806-013-944280600139415 g in 1 BOTTLE (42806-013-94) 15 g2022-09-150000-00-00NoNoCurrent
42806-013-9642806001396453.6 g in 1 JAR (42806-013-96) 453.6 g2014-04-140000-00-00NoNoCurrent