Home NDC 46287-012 Sodium Polystyrene Sulfonate
Product NDC 46287-012
11-digit product format 462870012
Labeler code 46287
Product ID 46287-012_ad780ec6-1a7e-4838-b833-6adb6bdbdb9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Polystyrene Sulfonate
Dosage form POWDER, FOR SUSPENSION
Route ORAL; RECTAL
Labeler CMP Pharma, Inc.
Application ANDA089910
Marketing category ANDA
Marketing start 1989-01-19
Substance SODIUM POLYSTYRENE SULFONATE
Active strength 1 g/g
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089910-001 SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089910-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089910-001 SODIUM POLYSTYRENE SULFONATE 454GM/BOT POWDER / ORAL, RECTAL AA 1989-01-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Polystyrene Sulfonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM POLYSTYRENE SULFONATE 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1699G8679Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2101899 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46287-012-16 Sodium Polystyrene Sulfonate 454 g in 1 JAR POWDER, FOR SUSPENSION 454 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46287-012 SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [CMP PHARMA, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20210202_2017bfbe-cda8-46f1-b4f1-9c086c3249a9.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46287-012-16 46287001216 454 g in 1 JAR (46287-012-16) 454 g 1989-01-19 0000-00-00 No No Current