Sodium Polystyrene Sulfonate

Product NDC
0054-0379
11-digit product format
000540379
Labeler code
0054
Product ID
0054-0379_c8a30664-07d6-4f9b-9c91-d5450df43705
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Polystyrene Sulfonate
Dosage form
SUSPENSION
Route
ORAL; RECTAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA089049
Marketing category
ANDA
Marketing start
2013-06-17
Marketing end
2021-01-31
Substance
SODIUM POLYSTYRENE SULFONATE
Active strength
15 g/60mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0379DDiscontinued by firm2026-08-17
excluded packagepackage0054-03790054-0379-50DDiscontinued by firm2026-08-17
excluded packagepackage0054-03790054-0379-51DDiscontinued by firm2026-08-17
excluded packagepackage0054-03790054-0379-55DDiscontinued by firm2026-08-17
excluded packagepackage0054-03790054-0379-63DDiscontinued by firm2026-08-17

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0379-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0379-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0379-63d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0379-55d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0379-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0379-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0379-63f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0379-55f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0379-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0379-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0379-632ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0379-552ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0379-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0379-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0379-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0379-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0379-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0379-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0379-63cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0379-55cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0379-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0379-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0379-63cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0379-55cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0379-51302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0379-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0379-63302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0379-55302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0379-51ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0379-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0379-63ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0379-55ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0379-510efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0379-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0379-630efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0379-550efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0379-51ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0379-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0379-63ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0379-55ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0379-51367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0379-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0379-63367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0379-55367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0379-51557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0379-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0379-63557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0379-55557ba5c1ecfa…9c80585c8c6e…

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
A089049-001SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17

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 06:07:402026-07A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA1986-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA1986-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA1986-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA1986-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089049-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTAL1986-11-17e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089049-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A089049-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089049-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089049-001AA1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0379-50ML - Milliliter0054-037965fb8cff-f71c-401d-beb7-a0d85d660e3012013-08-02
0054-0379-51ML - Milliliter0054-0379e2bc26e8-aafc-476e-9827-21e170dd3f6612014-09-03
0054-0379-55ML - Milliliter0054-0379a80dd7f8-1bbd-45bd-8d81-4580b6535aee12013-08-02
0054-0379-63ML - Milliliter0054-03791c5b423c-1882-4b89-b726-de03fbed434e12013-08-02

DailyMed Socrata Ingredients#