Sodium Polystyrene Sulfonate

Product NDC
46287-006
11-digit product format
462870006
Labeler code
46287
Product ID
46287-006_233303fe-cee1-420f-bf82-aaeb7850b01f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium polystyrene sulfonate
Dosage form
SUSPENSION
Route
ORAL; RECTAL
Labeler
CMP Pharma, Inc.
Application
ANDA087859
Marketing category
ANDA
Marketing start
1982-12-08
Substance
SODIUM POLYSTYRENE SULFONATE
Active strength
15 g/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A087859-001SPSSODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087859-001AA

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 06:07:402026-07A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALRLD, RS1982-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALRLD, RS1982-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALRLD, RS1982-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALRS1982-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALRS1982-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARS1982-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087859-001SPS15GM/60MLSUSPENSION / ORAL, RECTALAARLD, RS1982-12-08e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A087859-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087859-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087859-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087859-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087859-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087859-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087859-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087859-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087859-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087859-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087859-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087859-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087859-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087859-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087859-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087859-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087859-001AA15d02ea3f76ae…
2019-12-13 00:20 UTC2019-12A087859-001AA174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A087859-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087859-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087859-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087859-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087859-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087859-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087859-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087859-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087859-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087859-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087859-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087859-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087859-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087859-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087859-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087859-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087859-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087859-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087859-001AA1a50c72e98297…

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 SULFONATE15 g/60mL

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
313072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12d48dcf-07bd-4b06-bd6c-7543f1be8357Available 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46287-006-01Sodium Polystyrene Sulfonate473 mL in 1 BOTTLESUSPENSION4738
46287-006-04Sodium Polystyrene Sulfonate120 mL in 1 BOTTLESUSPENSION1208
46287-006-60Sodium Polystyrene Sulfonate60 mL in 1 BOTTLE, UNIT-DOSESUSPENSION608
46287-006-60Sodium Polystyrene Sulfonate10 in 1 CARTONSUSPENSION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46287-006-01ML - Milliliter46287-0062612ffc9-8d48-4dd1-88bb-08b959077ccc12012-07-24
46287-006-04ML - Milliliter46287-00668c9b36b-3438-4d21-aaa4-1ff6b67e999b12012-07-24
46287-006-60ML - Milliliter46287-0067f35ac4f-2acc-4130-a95e-555a6eb868da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM POLYSTYRENE SULFONATEACTIVE INGREDIENT1699G8679ZSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
POLYSTYRENE SULFONIC ACIDACTIVE MOIETY70KO0R01RYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CAROLINA MEDICAL PRODUCTS COMPANY]3
SODIUM POLYSTYRENE SULFONATEACTIVE INGREDIENT1699G8679ZSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
POLYSTYRENE SULFONIC ACIDACTIVE MOIETY70KO0R01RYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46287-006SODIUM POLYSTYRENE SULFONATE SUSPENSION [CMP PHARMA, INC.]8Current NDC, Legacy NDC, 4 package rows20210820_12d48dcf-07bd-4b06-bd6c-7543f1be8357.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECardinal Health 107, LLC3c3b02a3-9a75-40a5-889d-97318faf881f2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087859
application number: ANDA087859
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATECMP Pharma, Inc.12d48dcf-07bd-4b06-bd6c-7543f1be83572021-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087859
application number: ANDA087859
ndc (product): 46287-006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313072sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal SuspensionPSN3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 250 MG/ML Oral SuspensionSCD3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 15 GM per 60 ML Oral SuspensionSY3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 30 GM per 120 ML Oral SuspensionSY3c3b02a3-9a75-40a5-889d-97318faf881f10
313072sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal SuspensionPSN12d48dcf-07bd-4b06-bd6c-7543f1be83578
313072sodium polystyrene sulfonate 250 MG/ML Oral SuspensionSCD12d48dcf-07bd-4b06-bd6c-7543f1be83578
313072sodium polystyrene sulfonate 15 GM per 60 ML Oral SuspensionSY12d48dcf-07bd-4b06-bd6c-7543f1be83578
313072sodium polystyrene sulfonate 30 GM per 120 ML Oral SuspensionSY12d48dcf-07bd-4b06-bd6c-7543f1be83578

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46287-006-0146287000601473 mL in 1 BOTTLE (46287-006-01) 473 ml1982-12-080000-00-00NoNoCurrent
46287-006-0446287000604120 mL in 1 BOTTLE (46287-006-04) 120 ml1987-07-160000-00-00NoNoCurrent
46287-006-604628700066010 BOTTLE, UNIT-DOSE in 1 CARTON (46287-006-60) / 60 mL in 1 BOTTLE, UNIT-DOSE1985-12-120000-00-00NoNoCurrent