Sodium Polystyrene Sulfonate

Product NDC
17856-0024
Requested package NDC
17856-0024-2
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202333-001SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202333-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202333-001SODIUM POLYSTYRENE SULFONATE453.6GM/BOTPOWDER / ORAL, RECTALAA2014-03-19e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202333-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202333-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202333-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202333-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202333-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202333-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202333-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202333-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202333-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202333-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202333-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202333-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202333-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202333-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202333-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202333-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202333-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202333-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202333-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202333-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202333-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202333-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A202333-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202333-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202333-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202333-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A202333-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202333-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202333-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202333-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202333-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202333-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202333-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202333-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202333-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202333-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202333-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202333-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202333-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202333-001AA1e64feba35796…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1699G8679ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2101899Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d95d23e-94c8-4975-99f5-ce746dfbb60eAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
17856-0024-12025-03-18Sodium 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
17856-0024-22025-03-18Sodium 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
17856-0024-12025-01-30Sodium 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
17856-0024-22025-01-30Sodium 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEATLANTIC BIOLOGICALS CORP.2d95d23e-94c8-4975-99f5-ce746dfbb60e2025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202333
application number: ANDA202333
ndc (package): 17856-0024-2
ndc (product): 17856-0024
ndc11 (package): 17856002402
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEEpic Pharma, LLC61cc890b-eb3d-494c-ae45-629a27e721ce2023-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202333
application number: ANDA202333
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEPuraCap Laboratories, LLC875d5288-db99-4440-8290-d9192bde6eee2022-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202333
application number: ANDA202333

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
17856-0024-21785600240250 CUP in 1 BOX, UNIT-DOSE (17856-0024-2) / 30 g in 1 CUP50 cup2023-04-11NoNoCurrent