FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
10702-036
11-digit product format
107020036
Labeler code
10702
Product ID
10702-036_1213e349-d5ef-2221-e063-6294a90a8e83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Polystyrene Sulfonate
Dosage form
POWDER
Route
ORAL; RECTAL
Labeler
KVK-Tech, Inc.
Application
ANDA040905
Marketing category
ANDA
Marketing start
2012-07-25
Substance
SODIUM POLYSTYRENE SULFONATE
Active strength
1 g/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 SULFONATE1 g/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
10702-036-15Sodium Polystyrene Sulfonate15 g in 1 BOTTLEPOWDER159
10702-036-45Sodium Polystyrene Sulfonate454 g in 1 JARPOWDER4549

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-036-15GM - Gram10702-0361d6615b3-fe37-4592-a536-54061557bdf512013-02-13
10702-036-45GM - Gram10702-0368b55760e-d30a-4723-b73d-3db7b813046a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM POLYSTYRENE SULFONATEACTIVE INGREDIENT1699G8679ZSODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]4
POLYSTYRENE SULFONIC ACIDACTIVE MOIETY70KO0R01RYSODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-036SODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]9Current NDC, Legacy NDC, 2 package rows20240224_905c3ee5-d1a7-4deb-a345-4a42296704fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN905c3ee5-d1a7-4deb-a345-4a42296704fa9
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD905c3ee5-d1a7-4deb-a345-4a42296704fa9
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY905c3ee5-d1a7-4deb-a345-4a42296704fa9
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY905c3ee5-d1a7-4deb-a345-4a42296704fa9
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY905c3ee5-d1a7-4deb-a345-4a42296704fa9
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNe148d6d4-5abc-47c0-a365-8a14d03597a54
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDe148d6d4-5abc-47c0-a365-8a14d03597a54
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYe148d6d4-5abc-47c0-a365-8a14d03597a54
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYe148d6d4-5abc-47c0-a365-8a14d03597a54
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYe148d6d4-5abc-47c0-a365-8a14d03597a54
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN34fe6cd2-70f1-4ea3-adb7-a3e37defc8862
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD34fe6cd2-70f1-4ea3-adb7-a3e37defc8862
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY34fe6cd2-70f1-4ea3-adb7-a3e37defc8862
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY34fe6cd2-70f1-4ea3-adb7-a3e37defc8862
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY34fe6cd2-70f1-4ea3-adb7-a3e37defc8862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-036-151070200361515 g in 1 BOTTLE (10702-036-15) 15 g2015-04-030000-00-00NoNoCurrent
10702-036-4510702003645454 g in 1 JAR (10702-036-45) 454 g2012-07-250000-00-00NoNoCurrent