FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
62135-340
11-digit product format
621350340
Labeler code
62135
Product ID
62135-340_06fcec70-ae79-a194-e063-6394a90a6ffa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Polystyrene Sulfonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL; RECTAL
Labeler
Chartwell RX, LLC
Application
ANDA206815
Marketing category
ANDA
Marketing start
2016-02-18
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
62135-340-11Sodium Polystyrene Sulfonate10 in 1 BOXPOWDER, FOR SUSPENSION103
62135-340-11Sodium Polystyrene Sulfonate15 g in 1 BOTTLEPOWDER, FOR SUSPENSION153
62135-340-53Sodium Polystyrene Sulfonate453.6 g in 1 BOTTLEPOWDER, FOR SUSPENSION453.63
62135-340-62Sodium Polystyrene Sulfonate15 g in 1 BOTTLEPOWDER, FOR SUSPENSION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-340-11GM - Gram62135-340f416bb6a-84e6-4b36-b56d-25942705d90212022-11-07
62135-340-53GM - Gram62135-340e4f7eccd-589e-47ac-8587-1879b4f1e16d12022-11-07
62135-340-62GM - Gram62135-340c5b7685e-3171-4a6c-ba90-cd7cb91f6e8e12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-340SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 4 package rows20231006_e910a2f9-07ee-4e8f-95bd-f124e1306ff7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNe910a2f9-07ee-4e8f-95bd-f124e1306ff73
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDe910a2f9-07ee-4e8f-95bd-f124e1306ff73
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYe910a2f9-07ee-4e8f-95bd-f124e1306ff73
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYe910a2f9-07ee-4e8f-95bd-f124e1306ff73
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYe910a2f9-07ee-4e8f-95bd-f124e1306ff73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-340-116213503401110 BOTTLE in 1 BOX (62135-340-11) / 15 g in 1 BOTTLE10 bottle2022-07-200000-00-00NoNoCurrent
62135-340-5362135034053453.6 g in 1 BOTTLE (62135-340-53) 453.6 g2022-07-200000-00-00NoNoCurrent
62135-340-626213503406215 g in 1 BOTTLE (62135-340-62) 15 g2022-07-200000-00-00NoNoCurrent